FDA
Hearings Next Week on Boceprevir and Telaprevir for HCV
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| SUMMARY:
FDA Antiviral Drugs Advisory Committee will hear evidence
for boceprevir on April 27 and telaprevir on April 28. |
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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.
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.
