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

Where: 

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.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

 

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