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Hepatitis C Drug Simeprevir Submitted for FDA Review

More than 3 million people have HCV infection in U.S. (Mar. 28)

A new drug application (NDA) has been submitted to the FDA seeking approval for simeprevir (TMC435, Janssen), an investigational NS3/4A protease inhibitor, administered as a 150-mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype-1 chronic hepatitis C in adult patients.

Hepatitis C virus (HCV) infection is a blood-borne infectious disease of the liver that affects approximately 3.2 million people in the U.S. When left untreated, HCV infection can cause significant liver damage, including cirrhosis.

The regulatory submission for simeprevir was partly supported 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 interferon-based therapy. In each study, the participants were treated with one 150-mg simeprevir capsule once daily for 12 weeks plus pegylated interferon and ribavirin for 24 or 48 weeks.

Simeprevir (TMC435) is an investigational NS3/4A protease inhibitor for the treatment of genotype-1 chronic hepatitis C in adult patients with compensated liver disease. The drug is believed to work by blocking the protease enzyme that enables HCV to survive and replicate in host cells.

Source: Johnson & Johnson; March 28, 2013.

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