FDA committee recommends approval of Sovriad (Janssen) for Hepatitis C

The FDA's Antiviral Drugs Advisory Committee voted unanimously to recommend approval of Sovriad (simeprevir), from Janssen R&D, administered once daily as a 150 mg capsule with pegylated interferon and ribavirin for the treatment of genotype 1 chronic Hepatitis C in adult patients with compensated liver disease, including cirrhosis.

Submission for simeprevir is supported in part by data from three pivotal Phase III studies � QUEST-1 and QUEST-2 in treatment-naive patients and PROMISE in patients who have relapsed after prior interferon-based treatment � as well as data from the Phase IIb ASPIRE study in prior non-responder patients. The FDA granted a Priority Review designation in May to the New Drug Application (NDA) filed by Janssen for simeprevir.