Merck Submits NDA for Hepatitis C Drug
Merck & Co. has submitted a new drug application to the US Food and Drug Administration (FDA) for grazoprevir/elbasvir (100 mg/50 mg), an investigational once-daily, single tablet combination therapy for the treatment of adult patients with chronic hepatitis C virus (HCV) infection, genotypes (GT) 1, 4 or 6. 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.
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.
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 opiatesubstitution therapy.
Source: Merck & Co. Inc.