FDA Advisory Committee recommends approval of Merck's VICTRELIS for chronic HCV genotype 1 infection

Merck (NYSE:MRK) (known as MSD outside the United States and Canada) announced today that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted unanimously that the available data support approval of Merck's investigational medicine VICTRELIS™ (boceprevir) for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 infection in combination with current standard therapy. VICTRELIS is one of a new class of medicines known as HCV protease inhibitors being evaluated by the FDA for the treatment of chronic HCV genotype 1 infection in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.

“We're pleased with the panel's decision and look forward to working with the FDA as it continues to evaluate the application for VICTRELIS.”

The committee's recommendation will be considered by the FDA in its review of the New Drug Application for VICTRELIS. The FDA is not bound by the committee's guidance, but takes its advice into consideration when reviewing investigational medicines. The company anticipates FDA action on VICTRELIS by mid-May.

"The positive recommendation brings us one step closer to bringing VICTRELIS to men and women who need it, and reinforces our ongoing commitment to developing innovative therapies to treat chronic hepatitis C," said Peter S. Kim, Ph.D., president, Merck Research Laboratories. "We're pleased with the panel's decision and look forward to working with the FDA as it continues to evaluate the application for VICTRELIS."

The FDA granted priority review status for VICTRELIS, a designation for investigational medicines that address unmet medical needs. Additionally, the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for VICTRELIS for accelerated assessment.

The panel reviewed the results from the Phase III clinical study program for VICTRELIS; the clinical trials HCV SPRINT-2 and HCV RESPOND-2 included approximately 1,500 patients with chronic HCV genotype 1 infection, the most common form of the virus in the United States and most difficult to treat. Data that were discussed involved 1,097 treatment-naïve patients (HCV SPRINT-2) and 403 patients who failed previous therapy (HCV RESPOND-2). HCV SPRINT-2 included a separate analysis of results in African-American patients, a patient population that typically does not respond well to standard therapy. Results from HCV SPRINT-2 and HCV RESPOND-2 were published in the March 31 issue of the New England Journal of Medicine.

Source Merck