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.

If approved, the drug faces a highly competitive landscape of newly developed medicines for hepatitis C treatment. Gilead Sciences with Harvoni and AbbVie with Viekira Pak are two drug makers already gaining ground with new hepatitis C drugs approved by the FDA in 2014.

Companies that manage drug benefits for millions of patients have recently announced exclusive agreements with either Gilead or AbbVie for use of their hepatitis C treatments. Health officials estimate that at least 3 million people in the United States are infected with the hepatitis C virus, which can severely damage the liver over time.

Merck announced the NDA timeline as part of a multi-year strategy to sharpen its commercial and research development focus to become more competitive and innovative. Hepatitis C is among the core areas of the company’s research and development that is being accelerated.

“Over the past 15 months, we’ve seen the results of our transformation strategy, including advancing major pipeline candidates, completing multiple business development actions and securing first-in-class product approvals,” Kenneth C. Frazier, Merck’s chairman and chief executive officer said in a statement. “As a result of our strong and continued commitment to the pursuit of science and R&D, our labs are focused on many of the most innovative areas in biomedical research today, which we believe is the best way to create intrinsic value for both society and for our shareholders.”

In November 2014 at the meeting of the American Association for the Study of Liver Diseases, Merck released study results from a randomized, open-label phase 2 trial of grazoprevir plus elbasvir with or without ribavirin. The data indicated high rates of efficacy in previously untreated patients at both 12 and 18 weeks of treatment, according to Merck.

Merck enhanced its hepatitis development pipeline last year with the acquisition of Idenix Pharmaceuticals. Idenix was attractive to Merck because of its promising portfolio of hepatitis C drug candidates under development.

Merck expects the acquisition to help advance its goal to develop a highly effective once daily, oral, ribavirin-free pan-genotypic regimen to treat chronic infection of the virus.