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FDA Hearings Next Week on Boceprevir and Telaprevir for HCV

SUMMARY: FDA Antiviral Drugs Advisory Committee will hear evidence for boceprevir on April 27 and telaprevir on April 28.

Direct-acting antiviral agents that target steps of the hepatitis C virus (HCV) lifecycle are expected to revolutionize treatment over the next few years. The first drugs to reach the end of the pipeline -- running virtually neck-and-neck -- are 2 HCV protease inhibitors, Merck's boceprevir and Vertex's telaprevir.

Below are edited excerpts from recent U.S. Food and Drug Administration (FDA) announcements about Antiviral Drugs Advisory Committee hearings on these 2 new medications taking place next week in Silver Spring, MD.

The committee reviews evidence from clinical trials and makes recommendations to the agency as a whole. Committee recommendations are expected in late May with final FDA decisions coming this summer.


FDA Advisory Committee Meeting to Consider Boceprevir and
Telaprevir, April 27 and April 28, 2011

The Food and Drug Administration will convene its Antiviral Drugs Advisory Committee on April 27 and 28, 2011, to provide advice and recommendations to the Agency on two drugs intended to treat hepatitis C.

On April 27, 2011, the Committee will discuss a new drug application (NDA) 202-258, boceprevir (a hepatitis C virus protease inhibitor), manufactured by Merck & Co., Inc., 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 infection) in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.

On April 28, 2011, the Committee will discuss a new drug application (NDA) 201-917, telaprevir (a hepatitis C virus protease inhibitor), manufactured by Vertex Pharmaceuticals, Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.

Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.

The meetings will be held on both days from 8 a.m. to 5 p.m. at the FDA White Oak Campus, located at 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002.

Meeting Materials

FDA intends to make complete background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting.

2011 Meeting Materials, Antiviral Drugs Advisory Committee

Public Participation Information

These FDA advisory committee meetings are free and open to the public without prior registration. Oral presentations from the public will be scheduled between approximately 1:00 p.m. to 2:00 p.m. on both days.

Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee [Note: written testimony was due on April 14 and requests to give oral testimony were due April 6].

Please call the FDA Advisory Committee Information Line for up-to-date information on these meetings at 1-800-741-8138 (301-443-0572 in the Washington DC area). Enter code: 3014512531.

4/23/11

Source
R Klein and K Struble. FDA Advisory Committee meeting to consider boceprevir and telaprevir, April 27 and April 28, 2011.


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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