Merck & Co. plans to target hard-to-treat hepatitis C patients with its cure for the liver ailment rather than compete for market share by drastically undercutting the price of Gilead Sciences Inc.’s $1,000-a-day treatment.
Merck said Tuesday that the U.S. Food and Drug Administration accepted its application for approval of the single pill, which combines the medications grazoprevir and elbasvir, and granted the medicine a priority review. That means Merck is on course to introduce the treatment to the market early next year.
The field for hepatitis C patients is currently divided between AbbVie Inc. and Gilead, which have locked up arrangements with the leading managers of drug coverage in U.S. health insurance plans, ensuring their medications are the first choice. Still, Merck doesn’t foresee trouble attracting patients.
Read more...
Showing posts with label Merck. Show all posts
Showing posts with label Merck. Show all posts
Wednesday, July 29, 2015
Thursday, May 28, 2015
Merck Submits U.S. New Drug Application for Grazoprevir/Elbasvir, an Investigational Once-Daily, Single Tablet Combination Therapy, for Treatment of Chronic Hepatitis C Genotypes 1, 4, and 6 Infection
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the company has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for grazoprevir/elbasvir (100mg/50mg), an investigational once-daily, single tablet combination therapy for the treatment of adult patients with chronic hepatitis C genotypes (GT) 1, 4 or 6 infection. Within 60 days of submission, the FDA will determine whether it will accept for review Merck's application as filed. The company plans to submit additional license applications in the European Union and other markets by the end of 2015.
“Merck's submission is based on evidence from our wide-ranging clinical program assessing the efficacy and tolerability profile of grazoprevir/elbasvir in populations with chronic hepatitis C,” said Dr. Roy Baynes, senior vice president of clinical development, Merck Research Laboratories. “This submission to the U.S. FDA is an important milestone as we seek to provide patients with a new treatment option for this serious infection.”
The FDA has previously granted Breakthrough Therapy designation status for grazoprevir/elbasvir for the treatment of patients infected with chronic HCV GT1 with end stage renal disease on hemodialysis, and for patients infected with chronic HCV GT4. Breakthrough Therapy designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
The New Drug Application for grazoprevir/elbasvir (100mg/50mg) is based in part upon data from the pivotal C-EDGE clinical trials program, as well as the C-SURFER and C-SALVAGE trials, evaluating grazoprevir/elbasvir (100mg/50mg), with or without ribavirin, in patients with chronic hepatitis C infection. Data from these trials were presented at The International Liver CongressTM 2015 in April 2015.
About Grazoprevir/Elbasvir
Grazoprevir/elbasvir is an investigational, once-daily single tablet regimen consisting of grazoprevir (NS3/4A protease inhibitor) and elbasvir (NS5A replication complex inhibitor). As part of Merck’s broad clinical trials program, grazoprevir/elbasvir is being studied in multiple HCV genotypes and in patients with difficult-to-treat conditions such as HIV/HCV co-infection, advanced chronic kidney disease, inherited blood disorders, liver cirrhosis and those on opiate substitution therapy.
About Merck
Today’s Merck is a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
“Merck's submission is based on evidence from our wide-ranging clinical program assessing the efficacy and tolerability profile of grazoprevir/elbasvir in populations with chronic hepatitis C,” said Dr. Roy Baynes, senior vice president of clinical development, Merck Research Laboratories. “This submission to the U.S. FDA is an important milestone as we seek to provide patients with a new treatment option for this serious infection.”
The FDA has previously granted Breakthrough Therapy designation status for grazoprevir/elbasvir for the treatment of patients infected with chronic HCV GT1 with end stage renal disease on hemodialysis, and for patients infected with chronic HCV GT4. Breakthrough Therapy designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
The New Drug Application for grazoprevir/elbasvir (100mg/50mg) is based in part upon data from the pivotal C-EDGE clinical trials program, as well as the C-SURFER and C-SALVAGE trials, evaluating grazoprevir/elbasvir (100mg/50mg), with or without ribavirin, in patients with chronic hepatitis C infection. Data from these trials were presented at The International Liver CongressTM 2015 in April 2015.
About Grazoprevir/Elbasvir
Grazoprevir/elbasvir is an investigational, once-daily single tablet regimen consisting of grazoprevir (NS3/4A protease inhibitor) and elbasvir (NS5A replication complex inhibitor). As part of Merck’s broad clinical trials program, grazoprevir/elbasvir is being studied in multiple HCV genotypes and in patients with difficult-to-treat conditions such as HIV/HCV co-infection, advanced chronic kidney disease, inherited blood disorders, liver cirrhosis and those on opiate substitution therapy.
About Merck
Today’s Merck is a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Thursday, May 7, 2015
HCV Drugs, by Alan Franciscus, Editor-in-Chief
This month’s edition of HCV Drugs will be short due to the upcoming European Association for the Study of the Liver (EASL) conference. Join us for extensive coverage on www.hcvadvocate.org for the latest news and the next edition of the HCV Advocate newsletter. There is, however, important news included in this issue: Merck is granted Breakthrough Therapy designation; phase 2 study results of AbbVie’s combo to treat genotype 4; and, lastly not really drug-related, a new study that is being sponsored by the National Institutes of Health (NIH) that may finally help expand care and treatment to other medical providers.
Merck
Just when we thought that the Food and Drug Administration (FDA) had rescinded Breakthrough Therapy designation for all HCV therapies – we were wrong—they have given it to Merck’s combination of grazoprevir plus elbasvir for the treatment of people with HCV genotype 1 who have end-stage renal (kidney) disease on hemodialysis and for people with HCV genotype 4. The designation will allow for expedited review and approval.
Just when we thought that the Food and Drug Administration (FDA) had rescinded Breakthrough Therapy designation for all HCV therapies – we were wrong—they have given it to Merck’s combination of grazoprevir plus elbasvir for the treatment of people with HCV genotype 1 who have end-stage renal (kidney) disease on hemodialysis and for people with HCV genotype 4. The designation will allow for expedited review and approval.
Comment: These two groups are definitely in need of expedited review! This is very good news for people living with hepatitis C. Merck has this combination of medications in multiple studies.
Source: Company press release
AbbVie
Results from a small phase 2 trial was recently published in The Lancet. The trial included 86 HCV genotype 4 patients who had never been treated (treatment naïve) as well as those who had been treated previously (treatment-experienced). The patients were treated with ombitasvir (once-daily), paritaprevir/ritonavir—with and without ribavirin (twice daily) for 12 weeks.
Results from a small phase 2 trial was recently published in The Lancet. The trial included 86 HCV genotype 4 patients who had never been treated (treatment naïve) as well as those who had been treated previously (treatment-experienced). The patients were treated with ombitasvir (once-daily), paritaprevir/ritonavir—with and without ribavirin (twice daily) for 12 weeks.
Forty-nine patients who had previously received treatment (treatment-experienced) received the AbbVie combination treatment plus ribavirin for 12 weeks.
In the treatment-naïve group the cure rate was 100% in the group that received ribavirin and 91% in the group that did not receive ribavirin. In the treatment-experienced group the cure rate was 100%.
Comment: More good news for patients—although genotype 4 is uncommon in the United States it is estimated that about 13% of the global population (mostly in Egypt) is infected with genotype 4. However, when I conduct training workshops it always surprises me that there is usually one or more persons with genotype 4!
Source: Hézode C et al. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): A randomised, open-label trial. Lancet 2015 Mar 30; [e-pub].
NIH
The NIH and the city of Washington, D. C., with support from the NIH Office of AIDS Research has launched a study that will include 600 patients with HCV or HIV/HCV coinfection. Of the patients enrolled, 350 will continue with their current specialist, and 250 will be assigned to a primary care doctor, physician, physician assistant or nurse practitioner for treatment. The treatment will be Harvoni for two to six months.
Comments: There has always been a lack of medical providers to manage and treat people with hepatitis C. This is increasingly becoming a problem due to the increased awareness, testing and treatments that are easier to tolerate and more effective. Hopefully, this will show that more medical providers can safely and effectively manage and treat people with hepatitis C.
Source: NIH News press release
Friday, April 24, 2015
Merck’s Pivotal Phase 3 C-EDGE Program Evaluating Grazoprevir/Elbasvir Shows High Sustained Virologic Responses Across Broad Range of Patients with Chronic Hepatitis C Virus Infection
- Data Sets Include Treatment-Naïve, Treatment-Experienced and HIV Co-Infected Patients with Chronic Hepatitis C Virus Genotypes 1, 4 or 6 Infection
- Merck Remains on Track to Submit New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) in First Half of 2015
“Patients with co-morbidities and varying treatment experiences represent important segments of the chronic hepatitis C population in need of additional innovative treatment options,” said Dr. Eric Lawitz, vice president, scientific and research development, The Texas Liver Institute and clinical professor of medicine, The University of Texas Health Science Center, San Antonio. “These findings are important because they demonstrate that a single pill of grazoprevir/elbasvir taken once-daily achieved consistently high rates of SVR12 in the patient populations studied.”
| Summary of SVR12 findings: C-EDGE TN, C-EDGE CO-INFXN, C-EDGE TE | ||||||||||||
| C-EDGE TN | C-EDGE CO-INFXN | C-EDGE TE | ||||||||||
| Without RBV (n=316) | Without RBV (n=218) | Without RBV (n=105) | With RBV (n=104) | Without RBV (n=105) | With RBV (n=106) | |||||||
| Duration | 12 weeks | 12 weeks | 12 weeks | 12 weeks | 16 weeks | 16 weeks | ||||||
| All Patients: | 95% | 95% | 92% | 94% | 92% | 97% | ||||||
| SVR12 | (299/316) | (207/218) | (97/105) | (98/104) | (97/105) | (103/106) | ||||||
| Cirrhotic | 97% | 100% | 89% | 89% | 92% | 100% | ||||||
| (68/70) | (35/35) | (33/37) | (31/35) | (35/38) | (37/37) | |||||||
| Non-cirrhotic | 94% | 94% | 94% | 97% | 93% | 96% | ||||||
| (231/246) | (172/183) | (64/68) | (67/69) | (62/67) | (66/69) | |||||||
| Genotype 1a | 92% | 94% | 90% | 93% | 94% | 95% | ||||||
| (144/157) | (136/144) | (55/61) | (56/60) | (45/48) | (55/58) | |||||||
| Genotype 1b or | ||||||||||||
| other Genotype | 99% | 96% | 100% | 97% | 96% | 100% | ||||||
| 1 | (129/131) | (43/45) | (35/35) | (28/29) | (46/48) | (38/38) | ||||||
| Genotype 4 | 100% | 96% | 78% | 93% | 60% | 100% | ||||||
| (18/18) | (27/28) | (7/9) | (14/15) | (3/5) | (8/8) | |||||||
| Genotype 6 | 80% | 100% | 75% | 100% | ||||||||
| (8/10) | (1/1) | N/A | N/A | (3/4) | (2/2) | |||||||
C-EDGE TN Overview and Additional Findings
C-EDGE TN is a randomized, blinded, placebo-controlled trial evaluating the efficacy and safety of grazoprevir/elbasvir in treatment-naïve patients with or without cirrhosis infected with chronic HCV GT1, 4 or 6 who received therapy for 12 weeks. Patients were randomized to an immediate treatment group that received grazoprevir/elbasvir for 12 weeks or to a deferred treatment group that received placebo for 12 weeks, were followed for an additional four weeks, and then received open label grazoprevir/elbasvir for the next 12 weeks. The primary efficacy analysis included those patients who received immediate treatment with grazoprevir/elbasvir or placebo. Of the 316 patients who received immediate treatment with grazoprevir/elbasvir, 50 percent were infected with GT1a, 42 percent with GT1b, six percent with GT4 and three percent with GT6. Overall, 22 percent of patients had liver cirrhosis.
In this study, virologic failure occurred in 13 patients (4%) in the immediate treatment group, including one virologic breakthrough and 12 virologic relapses. Serious adverse events occurred in nine (3%) and three (3%) patients in the immediate treatment and corresponding placebo arms, respectively; none were considered drug-related. The most common adverse events reported (greater than 5% incidence) in the immediate treatment and corresponding placebo groups, were headache (17%, 18%), fatigue (16%, 17%), nausea (9%, 8%) and arthralgia (6%, 6%), respectively.
C-EDGE CO-INFXN Overview and Additional Findings
C-EDGE CO-INFXN is an open label, single-arm study evaluating the efficacy and safety of grazoprevir/elbasvir in treatment-naïve patients with or without cirrhosis infected with chronic HCV GT1, 4 or 6 and HIV who received therapy for 12 weeks. Of the 218 patients enrolled in the trial, 66 percent were infected with HCV GT1a, 21 percent with GT1b or other GT1, 13 percent with GT4, and one percent with GT6. Overall, 16 percent of patients had liver cirrhosis.
In this study, virologic failure occurred in seven patients (3%), including six virologic relapses and one reinfection. There were no reported drug-related serious adverse events. The most common (greater than 5% incidence) adverse events reported were fatigue (13%), headache (12%) and nausea (9%).
C-EDGE TE Overview and Additional Findings
C-EDGE TE is a randomized study evaluating the efficacy and safety of once-daily grazoprevir/elbasvir with or without twice-daily RBV in treatment-experienced (prior null response, partial response or relapse with peg-interferon/RBV) patients with or without cirrhosis infected with chronic HCV GT1, 4 or 6 who received therapy for 12 weeks or 16 weeks.
12 week arms
Of the 209 patients randomized to the 12 week arms, 105 patients received grazoprevir/elbasvir only and 104 patients received grazoprevir/elbasvir plus RBV. Patients in the grazoprevir/elbasvir only arm comprised 58 percent GT1a, 33 percent GT1b or other GT1 and nine percent GT4. Overall, 35 percent had liver cirrhosis. Among the 104 patients receiving grazoprevir/elbasvir plus RBV, 58 percent were infected with chronic HCV GT1a, 28 percent GT1b or other GT1, and 14 percent GT4. Overall, 34 percent had liver cirrhosis.
In the grazoprevir/elbasvir only and grazoprevir/elbasvir plus RBV arms, six patients in each arm (6%) were reported to have virologic relapse. No patients were reported to have virologic breakthrough or rebound. Serious adverse events were reported in four patients in the grazoprevir/elbasvir only arm (4%) and three patients in the grazoprevir/elbasvir plus RBV arm (3%). The most common (greater than 10% incidence) adverse events reported in the grazoprevir/elbasvir and grazoprevir/elbasvir plus RBV arms, respectively, were fatigue (19%, 27%), headache (21%, 20%) and nausea (9%, 14%).
16 week arms
Of the 211 patients enrolled in the 16 week arms, 105 patients received grazoprevir/elbasvir only and 106 patients received grazoprevir/elbasvir plus RBV. In the grazoprevir/elbasvir only arm, 46 percent were infected with chronic HCV GT1a, 46 percent with GT1b or other GT1, five percent with GT4 and four percent with GT6. Overall, 36 percent of patients had liver cirrhosis. Among those in the grazoprevir/elbasvir plus RBV arm, 55 percent were infected with chronic HCV GT1a, 36 percent with GT1b or other GT1, eight percent with GT4, and two percent with GT6. Overall, 35 percent had liver cirrhosis.
Among the patients receiving grazoprevir/elbasvir only, three patients (3%) were reported to have virologic breakthrough or rebound and four patients (4%) were reported to have virologic relapse. No virologic failures occurred in patients receiving grazoprevir/elbasvir plus RBV. Serious adverse events were reported in three patients in the grazoprevir/elbasvir only arm (3%) and four patients in the grazoprevir/elbasvir plus RBV arm (4%). The most common (greater than 10% incidence) adverse events reported in the grazoprevir/elbasvir and grazoprevir/elbasvir plus RBV arms, respectively, were fatigue (16%, 30%), headache (19%, 19%) and nausea (4%,17%).
About the C-EDGE Program
C-EDGE is the Phase 3 clinical development program for Merck’s investigational HCV treatment grazoprevir/elbasvir comprising five studies with more than 1,700 patients across more than 25 countries. These studies are evaluating grazoprevir/elbasvir in multiple genotypes (GT1, 4 and 6) and diverse patient populations, including difficult-to-treat patients such as: treatment-experienced, patients with cirrhosis, HIV/HCV co-infection, advanced chronic kidney disease, inherited blood disorders, and those receiving opiate substitution therapies.
Read complete press release here...
Merck oral hepatitis C regimen shows 95 pct cure rate
(Reuters) - Merck and Co Inc presented trial results on Friday showing that a once-daily combination of two experimental pills cured 95 percent of previously untreated hepatitis C patients after 12 weeks.
The trial included patients infected with the most common form of the liver-destroying virus, genotype 1, along with less common genotypes 4 and 6. It also involved patients with and without liver cirrhosis.
Cure rates, defined as sustained virologic response 12 weeks after treatment, were 92 percent for patients with genotype 1a; 99 percent for genotype 1b; 100 percent for genotype 4; and 80 percent for genotype 6. Cures were achieved in 97 percent of cirrhotic patients and 94 percent of non-cirrhotic patients.
Read more...
The trial included patients infected with the most common form of the liver-destroying virus, genotype 1, along with less common genotypes 4 and 6. It also involved patients with and without liver cirrhosis.
Cure rates, defined as sustained virologic response 12 weeks after treatment, were 92 percent for patients with genotype 1a; 99 percent for genotype 1b; 100 percent for genotype 4; and 80 percent for genotype 6. Cures were achieved in 97 percent of cirrhotic patients and 94 percent of non-cirrhotic patients.
Read more...
Thursday, April 23, 2015
Merck Announces Results from Phase 2/3 Study of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir in Patients with Advanced Chronic Kidney Disease
C-SURFER Trial is First to Investigate an All-Oral Ribavirin-Free Hepatitis C Treatment Regimen in Treatment-Naïve and Treatment-Experienced Patients with Advanced Chronic Kidney Disease Infected with Hepatitis C Virus Genotype 1
VIENNA--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first presentation of data from C-SURFER, the company’s Phase 2/3 clinical trial evaluating the investigational once-daily treatment regimen of grazoprevir (100mg) and elbasvir (50mg) in patients with advanced chronic kidney disease (CKD) infected with chronic hepatitis C virus (HCV) genotype 1 (GT1).1 Treatment-naïve patients and patients who failed prior pegylated interferon HCV therapy, with or without cirrhosis, all of whom had CKD stages 4 or 5, were enrolled.2 Following 12 weeks of treatment with grazoprevir and elbasvir, 99 percent (115/116) of patients in the pre-specified primary population for analysis of efficacy data achieved a sustained virologic response 12 weeks after the completion of treatment (SVR12).3 These data will be presented today at The International Liver CongressTM 2015 – the 50th annual congress of the European Association for the Study of the Liver (late breaking E-Poster #LP02).
“There is an unmet medical need to treat chronic hepatitis C virus infection in patients with advanced chronic kidney disease,” said Dr. Howard Monsour, Jr., chief of hepatology, Houston Methodist Hospital, Houston, Texas. “In this trial, the first to investigate an all-oral ribavirin-free treatment regimen in treatment-naïve and treatment-experienced CKD patients, treatment with grazoprevir and elbasvir for 12 weeks was effective in this study population with HCV genotype 1 infection.”
The ongoing C-SURFER Phase 2/3 clinical trial is a randomized, parallel-group, placebo-controlled study evaluating patients infected with chronic HCV GT1 with advanced CKD with or without liver cirrhosis. Patients were randomized to one of two study arms:
- Immediate treatment group (ITG), grazoprevir plus elbasvir (blinded) once-daily for 12 weeks (n=111);
- Deferred treatment group (DTG), initially placebo (control arm) for 12 weeks followed by a four week follow-up period and then treatment with grazoprevir plus elbasvir (open label) once-daily for 12 weeks (n=113).
Of the 122 patients who received grazoprevir plus elbasvir, 83 percent were treatment-naïve, 36 percent had diabetes, 18 percent had stage 4 CKD, 82 percent had stage 5 CKD, 75 percent were receiving hemodialysis and 45 percent were African-American. Among those patients who received at least one dose of grazoprevir plus elbasvir, five percent (6/122) were excluded from the pre-specified primary efficacy analysis population, or modified full analysis set, due to missing data caused by death or early discontinuation for reasons unrelated to study drug. In the modified full analysis set, 99 percent (115/116) of patients receiving grazoprevir plus elbasvir achieved SVR12. One GT1b infected, non-cirrhotic, interferon-intolerant patient showed a viral relapse at follow-up week 12. Within the modified full analysis set, efficacy was consistent across the patient sub-populations assessed. In a supportive analysis of all 122 patients who received at least one dose of grazoprevir plus elbasvir in the ITG arms, including patients who did not complete the study for reasons not related to study drug, 94 percent (115/122) of patients achieved SVR12.
“Merck’s broad clinical development program includes studies dedicated to bringing a once-daily regimen to diverse populations of patients infected with chronic HCV, including certain types of patients with co-morbidities, such as advanced chronic kidney disease,” said Dr. Eliav Barr, vice president, infectious diseases, Merck Research Laboratories. “These data highlight how emerging innovations in chronic hepatitis C treatment may lead to new options for patient populations in which it historically has been difficult to achieve high rates of sustained viral clearance.”
No patients in the ITG arms discontinued treatment due to adverse events (AEs), while four percent (5/113) of patients in the comparator placebo phase of the DTG arm discontinued treatment due to AEs. The rates of serious AEs reported were 14 percent (16/111) in the ITG arms and 17 percent (19/113) in the placebo control DTG arm. The most common treatment-related AEs in the ITG arms and DTG arm (placebo) were headache (17%, 17%), nausea (15%, 16%) and fatigue (10%, 15%), respectively. There were four deaths reported during the initial treatment phase and the first 14 days of study follow-up. One patient (1%) in the open label arm died from cardiac arrest (not considered related to study medicine) and three patients (2%) in the placebo group died from aortic aneurysm, pneumonia and an unknown cause.
On April 8, 2015, the company announced that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Therapy designation to grazoprevir/elbasvir for the treatment of patients infected with chronic HCV GT1 with end-stage renal disease on hemodialysis and patients infected with chronic HCV GT4. Breakthrough Therapy designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
About C-SURFER
C-SURFER is a Phase 2/3 clinical trial evaluating Merck’s investigational grazoprevir plus elbasvir in patients infected with chronic HCV GT1 and with advanced chronic kidney disease (stages 4 and 5, including patients on hemodialysis) with or without liver cirrhosis, which are among those with HCV infection who are most difficult to treat, over 12 weeks.
About Chronic HCV Infection and Chronic Kidney Disease
Chronic HCV infection is both a cause and complication of the treatment of CKD. In patients with CKD, chronic HCV infection is associated with an increased risk of accelerated loss of remaining kidney function, kidney transplant failure and death. Furthermore, patients with chronic HCV infection and advanced CKD represent an unmet need due to a lack of demonstrated HCV treatment options for this group.
About Grazoprevir/Elbasvir
Grazoprevir/elbasvir is an investigational, once-daily single tablet regimen consisting of grazoprevir (NS3/4A protease inhibitor) and elbasvir (NS5A replication complex inhibitor). As part of Merck’s broad clinical trials program, grazoprevir/elbasvir is being studied in multiple HCV genotypes and in patients with difficult-to-treat conditions such as HIV/HCV co-infection, advanced chronic kidney disease, inherited blood disorders, liver cirrhosis and those on opiate substitution therapy.
Read complete press release here...
Wednesday, February 4, 2015
UPDATE 2-Merck says hepatitis C treatment to lose "breakthrough" status
Feb 4 (Reuters) - Merck & Co on Wednesday said the U.S. Food and Drug Administration intends to rescind its "breakthrough therapy" designation for the company's experimental combination treatment for hepatitis C because of other recently approved treatments.
Merck, in its fourth-quarter earnings report, said it plans to discuss the matter with the FDA, and still expects to seek U.S. approval for the treatment in the first half of 2015. It consists of a protease inhibitor called MK-5172 and a so-called NS5A inhibitor called MK-8742 that together had received the "breakthrough therapy" designation from the FDA.
The setback for Merck's treatment follows recent approvals of costly oral treatments for the liver disease from Gilead Sciences Inc and AbbVie that have wiped out all signs of the virus in more than 90 percent of patients after eight or 12 weeks.
Read more....
Tuesday, February 3, 2015
HCV Drugs: Triple Drug Regimens, Exclusivity Deals, Merck & Gilead Updates —Alan Franciscus, Editor-in-Chief
At last year’s CROI conference, I wrote about a 6-week study of sofosbuvir, ledipasvir, and GS-9451. This combination was tested against sofosbuvir/ledipasvir alone for 12 weeks and sofosbuvir/ledipasvir plus GS-9669 for 6 weeks. The drugs were combined into one-pill, taken once-daily. There were 20 patients in each arm.
The bottom line is that all 20 patients (100%) achieved a cure in the triple combination of sofosbuvir/ledipasvir and GS-9669 with 6 weeks of treatment. The most common side effects were headache, fatigue and diarrhea.
Comments: This study is a small study and there is currently no information that it has yet entered into phase 3 studies. But given the high cure rates and low side effects hopefully it will be entered into clinical trials with this combination or perhaps Gilead is researching another inhibitor to include.
Study: Virological response after 6 week triple-drug regimens for hepatitis C: a proof-of-concept phase 2A cohort study. Authors: A Kohli et al.
Exclusivity Deals
Ever since AbbVie’s VIEKIRA PAK’s approval there have been intense negotiations between insurance companies/pharmacies and AbbVie and Gilead to determine who will be the exclusive distributors of the pharmaceutical HCV medications. These deals will help to drive down the costs of the drugs, and this will hopefully translate into more patients having access to HCV medications. The real downside is that the decision as to which medication a patient should be prescribed is now being made by someone other than a patient and medical provider. This is very bad news for patients (see "Predictors" article). The information below is from our blog as of the date that we have put together our newsletter. If you have been denied treatment in the past, you may want to check the list below (or our Blog) to find out if you would now qualify for insurance coverage. The agreements are on-going so keep checking back.
Ever since AbbVie’s VIEKIRA PAK’s approval there have been intense negotiations between insurance companies/pharmacies and AbbVie and Gilead to determine who will be the exclusive distributors of the pharmaceutical HCV medications. These deals will help to drive down the costs of the drugs, and this will hopefully translate into more patients having access to HCV medications. The real downside is that the decision as to which medication a patient should be prescribed is now being made by someone other than a patient and medical provider. This is very bad news for patients (see "Predictors" article). The information below is from our blog as of the date that we have put together our newsletter. If you have been denied treatment in the past, you may want to check the list below (or our Blog) to find out if you would now qualify for insurance coverage. The agreements are on-going so keep checking back.
- AbbVie: Express Scripts, AIDS Drug Assistance Programs (ADAPs)
- Gilead: Aetna, Humana, Anthem, CVS
- Both—AbbVie/Gilead: Prime Therapeutics
Merck
In January, Merck announced that it has been prioritizing portions of its drug development operations including hepatitis C. In this respect, the development of a two-drug single pill (grazoprevir/elbasvir) will be accelerated. Merck hopes to apply for marketing approval in the first half of 2015. The combination is currently in phase 3 studies. Phase 2 studies of the two drug combination with and without ribavirin in multiple arm studies of monoinfected and HIV/HCV coinfected patient populations with and without cirrhosis resulted in cure rates from 90 to 100%. The most common side effects were fatigue, headache and general weakness.
Gilead
Gilead has announced that it has expanded its hepatitis C generic licensing agreements to include the investigational NS5A inhibitor GS-5816, which is being evaluated in Phase 3 clinical studies as part of a single tablet regimen that combines the compound and sofosbuvir for the treatment of all six genotypes of hepatitis C. If approved by regulatory authorities, the sofosbuvir/GS-5816 regimen would become the first pan-genotypic, all-oral single tablet regimen for HCV. A pan-genotypic therapeutic option is particularly important for developing countries, where genotype testing is often unreliable or not readily available.
http://hcvadvocate.org/news/newsLetter/2015/advocate0215.html#2
Wednesday, January 21, 2015
Merck Will No Longer Sell its Victrelis Hepatitis C Drug in the U.S.
Rival hepatitis C drugs from Merck and Vertex Pharmaceuticals VRTX +0.21% made a big splash when they debuted in 2011, marking an advance in treatment of the liver disease and a lucrative new market segment. But now the Class of 2011 has almost sunk to the bottom, made obsolete by a newer wave of drugs, a sign of how rapidly the hepatitis C market is changing.
Merck this week notified the FDA that it will stop selling its Victrelis medicine in the U.S. by the end of this year, although the drug will remain available in other countries. The move comes three months after Vertex Pharmaceuticals discontinued U.S. sales of its own Incivek hepatitis C drug.
Both drugs are known as protease inhibitors and when they became available in 2011, they were quickly incorporated into treatment. Victrelis and Incivek each boosted cure rates and shortened treatment durations for many patients when added to the prior standard treatment.
Read more...
Merck this week notified the FDA that it will stop selling its Victrelis medicine in the U.S. by the end of this year, although the drug will remain available in other countries. The move comes three months after Vertex Pharmaceuticals discontinued U.S. sales of its own Incivek hepatitis C drug.
Both drugs are known as protease inhibitors and when they became available in 2011, they were quickly incorporated into treatment. Victrelis and Incivek each boosted cure rates and shortened treatment durations for many patients when added to the prior standard treatment.
Read more...
Wednesday, January 14, 2015
Merck to Seek Approval of New Hepatitis C Drug by Midyear
If all goes as planned, Merck will soon take a major step forward in the hot pursuit among pharmaceutical companies to produce a newer, better, faster-working drug to treat the millions of people who have chronic hepatitis C infection.
By midyear the company expects to submit a New Drug Application to the Food and Drug Administration for approval of grazoprevir/elbasvir, a combination regimen investigational drug designed to be taken once daily as treatment of chronic hepatitis C virus infection. Grazoprevir is an NS3/4A second-generation protease inhibitor and elbasvir is an NS5A inhibitor.
- See more at: http://www.hcplive.com/articles/Merck-to-Seek-Approval-of-New-Hepatitis-C-Drug-by-Midyear#sthash.maxgPR9Q.dpuf
By midyear the company expects to submit a New Drug Application to the Food and Drug Administration for approval of grazoprevir/elbasvir, a combination regimen investigational drug designed to be taken once daily as treatment of chronic hepatitis C virus infection. Grazoprevir is an NS3/4A second-generation protease inhibitor and elbasvir is an NS5A inhibitor.
- See more at: http://www.hcplive.com/articles/Merck-to-Seek-Approval-of-New-Hepatitis-C-Drug-by-Midyear#sthash.maxgPR9Q.dpuf
Monday, January 12, 2015
Merck Accelerates Lung Cancer, Hepatitis C Drugs
Merck plans to file an application with the U.S. Food and Drug Administration in the first half of 2015 for the grazoprevir and elbasvir once-daily combination hepatitis C medicine, the company said in a statement today, joining AbbVie Inc. (ABBV:US) and Gilead Sciences Inc. (GILD:US) in creating drug cocktails that can treat the disease in many patients. Merck also plans to apply for permission to expand use of the melanoma treatment Keytruda into non-small cell lung cancer patients.
Merck replaced its head of research in 2013 with Roger Perlmutter and focused development efforts on oncology, hepatitis C, cardiometabolic disease, antimicrobial resistance and Alzheimer’s disease. The Kenilworth, New Jersey-based company has needed new approvals to make up for a decline in sales from the asthma drug Singulair, which lost patent protection in the U.S. in 2012 and in Europe in 2013. Singulair sales fell from $5.5 billion in 2011 to $1.2 billion in 2013.
Read more...
Merck replaced its head of research in 2013 with Roger Perlmutter and focused development efforts on oncology, hepatitis C, cardiometabolic disease, antimicrobial resistance and Alzheimer’s disease. The Kenilworth, New Jersey-based company has needed new approvals to make up for a decline in sales from the asthma drug Singulair, which lost patent protection in the U.S. in 2012 and in Europe in 2013. Singulair sales fell from $5.5 billion in 2011 to $1.2 billion in 2013.
Read more...
Subscribe to:
Posts (Atom)