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Merck Submits New Drug Application for Grazoprevir/Elbasvir for HCV

Merck announced that the company has submitted a new drug application to the FDA for grazoprevir/elbasvir for the treatment of adults with chronic hepatitis C genotype 1, 4 or 6 infection, according to a press release.

The application for grazoprevir/elbasvir (MK-5172, MK-8742; Merck) is based upon data from the C-EDGE, C-SURFER and C-SALVAGE trials, which all evaluated the combination regimen in patients with chronic HCV, according to the release.

“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,” Roy Baynes, senior vice president of clinical development, Merck Research Laboratories, said in the release. “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 granted new breakthrough designation for grazoprevir/elbasvir in April after rescinding a previous breakthrough designation due to the availability of other new drugs for HCV.

The FDA will determine whether it will accept for review Merck’s application as filed within 60 days of submitting the application, according to the release. The company plans to submit additional license applications in the European Union and other markets by the end of 2015.

Disclosure: Baynes is employed by Merck.