This month’s column discusses Merck’s New Drug Application (NDA) application to the Food and Drug Administration (FDA), BMS’s Breakthrough Designation, a pharmaceutical collaboration, and good news for patients who need help with co-payments for HCV medications.
Merck
On May 28, 2015, Merck submitted a NDA to the FDA for their combination of one pill (grazoprevir/elbasvir) taken once-a-day to treat HCV genotypes 1, 4 and 6. Merck’s combination was granted Breakthrough Therapy designation status for the combination by the FDA for people with genotype 1 with end state kidney disease on hemodialysis (to filter the kidneys) and for patients with genotype 4. Breakthrough Therapy is given to a drug(s) to treat a serious or life-threatening disease or condition when a drug may demonstrate a substantial improvement over existing therapies. There were many reports on Merck’s HCV medications from EASL 2015 that resulted in cure rates up to 95-99% in people with genotype 1; 100% in genotype 4 and 80% in genotype 6.
On May 28, 2015, Merck submitted a NDA to the FDA for their combination of one pill (grazoprevir/elbasvir) taken once-a-day to treat HCV genotypes 1, 4 and 6. Merck’s combination was granted Breakthrough Therapy designation status for the combination by the FDA for people with genotype 1 with end state kidney disease on hemodialysis (to filter the kidneys) and for patients with genotype 4. Breakthrough Therapy is given to a drug(s) to treat a serious or life-threatening disease or condition when a drug may demonstrate a substantial improvement over existing therapies. There were many reports on Merck’s HCV medications from EASL 2015 that resulted in cure rates up to 95-99% in people with genotype 1; 100% in genotype 4 and 80% in genotype 6.
Merck states that they will be notified within 60 days if the FDA will accept their application for review. Furthermore, Merck is expected to file additional licenses in the European Union and other markets by the end of 2015. This will be good news for paients—we may just have another choice of medications in the near future.
BMS
Bristol-Myers-Squibb announced that they have been granted Breakthrough Therapy Designation by the FDA for the combination of daclatasvir and sofosbuvir. The cure rates of Daclatasvir, sofosbuvir and ribavirin performed well in liver transplant patients and in those who had advanced cirrhosis. I reported on a study from EASL 2015 that in this population there was a cure rate of 76% to 100%.
Bristol-Myers-Squibb announced that they have been granted Breakthrough Therapy Designation by the FDA for the combination of daclatasvir and sofosbuvir. The cure rates of Daclatasvir, sofosbuvir and ribavirin performed well in liver transplant patients and in those who had advanced cirrhosis. I reported on a study from EASL 2015 that in this population there was a cure rate of 76% to 100%.
Achillion and J&J Deal
It was announced in May that Johnson and Johnson would collaborate with Achillion. The deal would mean that J & J would invest in and help develop Achillion’s HCV 3 drug pipeline. The three drugs are all in early development and could work on all HCV genotypes, i.e., be pan-genotypic. J & J hopes to co-develop their drug pipeline with Achillion and achieve an effective 6-week HCV treatment cure.
It was announced in May that Johnson and Johnson would collaborate with Achillion. The deal would mean that J & J would invest in and help develop Achillion’s HCV 3 drug pipeline. The three drugs are all in early development and could work on all HCV genotypes, i.e., be pan-genotypic. J & J hopes to co-develop their drug pipeline with Achillion and achieve an effective 6-week HCV treatment cure.
Co-Pay Assistance
The current medications to treat hepatitis C can have high co-payments. Presented here is another co-pay assistant program for patients—HealthWell Foundation’s New Fund. For more information visit their website at http://healthwellfoundation.org/ or contact: Ginny Dunn 240-632-5309, email Ginny.Dunn@HealthWellFoundation.org
http://hcvadvocate.org/news/newsLetter/2015/advocate0615_mid.html#4
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