HCV drugs simeprevir, sofosbuvir earn positive FDA reviews before advisory board votes

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The FDA Antiviral Drugs Advisory Committee will review  Gilead's Sofosbuvir on October 25th and Johnson & Johnson's Simeprevir on October 24th.

Download background information for Sofosbuvir and Simeprevir prepared by the Food and Drug Administration (FDA) for the panel members of the advisory committee. 

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FDA Updates For Sofosbuvir
FDA Updates For Simeprevir

The FDA is scheduled to decide whether to approve sofosbuvir by December 8th, and simeprevir by November 27th.

FDA Issues Positive Review for Gilead's Sofosbuvir Hepatitis C Drug
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HCV drugs simeprevir, sofosbuvir earn positive FDA reviews before advisory board votes
October 23, 2013

Two hepatitis C drugs, simeprevir and sofosbuvir, received promising internal FDA reviews on the eve of advisory board meetings at which government experts will decide whether to recommend approval for both medications.

A background report submitted to the FDA Antiviral Drugs Advisory Committee concluded that simeprevir (Johnson & Johnson), in combination with pegylated interferon-alpha and ribavirin (PR), was superior to placebo in achieving a sustained virologic response in treatment-naive patients with HCV and those who relapsed after prior PR therapy.

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