FDA Antiviral Drugs Advisory Committee recommends approval for J&J hepatitis C drug

Panel, with 19 members, votes unanimously

NEW YORK — A Food and Drug Administration expert panel has recommended approval for a drug made by Johnson & Johnson for treating hepatitis C, the company said.

J&J subsidiary Janssen Research & Development said the 19-member FDA Antiviral Drugs Advisory Committee voted unanimously to recommend approval for TMC435 (simeprevir), a 150-mg drug meant for administration once per day with the generic antiviral ribavirin and a biotech drug known as an interferon, for treating genotype 1 chronic hepatitis C.

"We are pleased with the positive recommendation from the advisory committee for simeprevir and appreciate the rigorous review of our data," Janssen medical department head for infectious diseases Katia Boven said. "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."


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