Merck Submits US NDA for Grazoprevir Elbasvir for Treatment of Chronic Hepatitis C Genotypes 1, 4, and 6 Infection

Merck (MSD outside the US and Canada) has announced that the company has submitted a New Drug Application (NDA) to the 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 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 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 NDA 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 (100 mg/50 mg), with or without ribavirin, in patients with chronic hepatitis C infection.