Meeting Announcement – Simeprevir

Posted by on October 1, 2013

October 24, 2013 8:00 a.m. to 5:00 p.m.: Antiviral Drugs Advisory Committee Meeting Announcement


Sheraton Silver Spring Hotel

Cypress Ballroom

8777 Georgia Avenue

Silver Spring, Maryland


The committee will discuss a new drug application (NDA) 205123, simeprevir (a hepatitis C virus protease inhibitor), manufactured by Janssen Pharmaceutical Co., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin (two medicines approved to treat chronic hepatitis C) in adult patients with compensated liver disease (including cirrhosis) who are treatment-naïve or who have failed previous interferon therapy (pegylated or non-pegylated) with or without ribavirin. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.

Please click  HERE for the current roster of the Antiviral Drugs Advisory Committee.

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