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FDA Advisors Recommend Approval of Simeprevir for Treatment of Hepatitis C
The FDA’s Antiviral Drugs Advisory Committee has voted unanimously (19 to 0) to recommend approval of the investigational protease inhibitor simeprevir (TMC435, Janssen) administered once daily as a 150-mg capsule with pegylated interferon (IFN) and ribavirin for the treatment of genotype-1 chronic hepatitis C in adults with compensated liver disease, including cirrhosis.
The FDA will consider the committee’s recommendation in its review of the new drug application (NDA) for simeprevir, but the agency is not obligated to follow its advisors’ suggestions.
The regulatory submission for simeprevir was supported in part by data from three pivotal phase III studies — QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in patients who had relapsed after prior IFN-based treatment — as well as by data from the phase IIb ASPIRE study in prior nonresponders.
Simeprevir is an investigational NS3/4A protease inhibitor developed for the treatment of genotype-1 and genotype-4 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis. The drug works by blocking the protease enzyme that enables the hepatitis C virus to replicate in host cells.
Source: PR Newswire; October 24, 2013.