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, 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
& 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. (Google
FDA intends to make background material about these meetings
available to the public no later than 2 business days before
the meeting at www.fda.gov/AdvisoryCommittees/Calendar/default.htm.
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
Written submissions may be made to
Paul Tran, R.Ph
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
on or before April 14, 2011.
Oral presentations from the public will be scheduled between
approximately 1:00 p.m. to 2:00 p.m., on April 28, 2011. Those
desiring to make formal oral presentations should notify Paul
Tran and submit a brief statement of the general nature of the
evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate
time requested to make their presentation on or before April
Time allotted for each presentation may be limited. If the number
of registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session,
FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by
April 7, 2011.
Please call the FDA Advisory Committee Information Line
for up-to-date information on this meeting at 1-800-741-8138
(301-443-0572 in the Washington DC area). Enter code: 3014512531.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Paul Tran
at (301) 796-9001 at least 7 days in advance of the meeting.
Information regarding special accommodations due to a disability,
or information about visitor parking and transportation may
be accessed at: Public
Meetings at the FDA White Oak Campus.
Please visit our Web site at Public
Conduct During FDA Advisory Committee Meetings for procedures
on public conduct during advisory committee meetings. FDA is
committed to the orderly conduct of its advisory committee meetings.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
R Klein and K Struble, Food and Drug Administration. FDA Advisory
Committee Meeting to Consider Boceprevir and Telaprevir, April
27 and April 28, 2011. FDA Hepatitis Update. March 15, 2011.