FDA
25th October 2013

FDA Panel Recommends Approval of Simeprevir for Hepatitis C

Yesterday, the US Food and Drug Administration’s (FDA’s) Antiviral Drugs Advisory Committee unanimously recommended simeprevir (Janssen) for the treatment of chronic hepatitis C virus.

FDA Panel Recommends Approval of Simeprevir for Hepatitis C

Yesterday, the US Food and Drug Administration’s (FDA’s) Antiviral Drugs Advisory Committee unanimously recommended simeprevir (Janssen) for the treatment of chronic hepatitis C virus (HCV) genotype 1 (GT1) infection, combined with peginterferon alfa and ribavirin in adults with compensated liver disease (including cirrhosis) who are treatment naïve or who have failed previous interferon therapy with or without ribavirin.

Simeprevir is an HCV protease inhibitor, and if approved it will be the third HCV protease inhibitor approved in the US. The proposed dose is 150 mg once daily, in combination with peginterferon alfa and ribavirin.

According to background information provided by the FDA, similar drugs such as Boceprevir (Victrelis, Merck) and telaprevir (Incivek, Vertex Pharmaceuticals, Inc) were approved in 2011. 

“We clearly need better drugs, and the evidence is strong that this is a better drug than we have,” Voting member Curt H. Hagedorn, MD, Chief, Medicine Service, at Central Arkansas Veterans Healthcare Service, in Little Rock, Arkansas noted.

Data from 3 phase 3 randomized, double-blind, placebo controlled clinical trials (C208, C216, and HPC3007) in patients with chronic HCV GT1 were discussed before the vote took place. Patients in the treatment groups (N = 781) were given simeprevir 150 mg daily for 12 weeks plus peginterferon and ribavirin (PR) for 12 weeks, followed by PR only for either 12 or 36 weeks based on the individual’s virologic response to therapy. Patients in the control groups (N = 397) were given placebo for 12 weeks combined with PR for 48 weeks.

Those in trials C208 and C216 were treatment-naïve, and those in HPC3007 had received 24 weeks or more of a pegylated interferon-based treatment and had relapsed within 1 year after the last medication dose. Efficacy data from C208 and C216 were pooled because the studies were nearly identical in design.

“We are pleased with the positive recommendation from the Advisory Committee for simeprevir and appreciate the rigorous review of our data,” stated Katia Boven, M.D., Medical Department Head, Infectious Diseases and Vaccines, Janssen. “It is our hope that the FDA will consider this recommendation and, upon completion of its review process, make simeprevir available to patients with genotype 1 chronic hepatitis C,” Boven added.

The FDA is not obligated to follow the advice of its committees; however, they normally do so.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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