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FDA Advisory Committee meeting to consider boceprevir and telaprevir, April 27 and April 28, 2011The 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, from 8 a.m. to 5 p.m., the Committee will discuss a new drug application (NDA) 202–258, boceprevir (a hepatitis C virus protease inhibitor), manufactured by Merck（默克公司） & 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 (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.
Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.
The meeting 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.
Please note that visitors to the White Oak Campus must enter through Building 1, which is located at the circle at the entrance to the campus via Mahan Road from New Hampshire Avenue. ([url=http://maps.google.com/maps?q=10903%2Bnew%2Bhampshire%2Bavenue%2Bsilver%2Bspring&oe=utf-8&rls=org.mozilla:en-US fficial&client=firefox-a&um=1&ie=UTF-8&hq=&hnear=10903%2BNew%2BHampshire%2BAve,%2BSilver%2BSpring,%2BMD%2B20903&gl=us&ei=IwmATbn3HKaJ0QGzmJSLCQ&sa=X&oi=geocode_result&ct=image&resnum=1&ved=0CBYQ8gEwAA]Google Maps[/url]1)
FDA intends to make background material about these meetings available to the public no later than 2 business days before the meeting at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm2.
Scroll down to the link for the Antiviral Drug Committee, and click on appropriate meeting dates.
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.
Public Participation Information
This FDA advisory committee meeting is free and open to the public without prior registration.
Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee.
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发表于 2011-4-2 09:21
$250 million 