FDA Hepatitis Update - FDA Advisory Committee meeting to consider boceprevir and telaprevir, April 27 and April 28, 2011

March 16, 2011

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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 Maps)

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.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 the committee.

Written submissions may be made to

Tran, R.Ph

Center for Drug Evaluation and Research

Food and Drug Administration

10903 New Hampshire Avenue

WO31-2417

Silver Spring, MD 20993-0002

Phone: 301-796-9001

Fax: 301-847-8533

E-mail: .Tran@...

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 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 6, 2011.

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 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 outlets.

Klein

Office of Special Health Issues

Food and Drug Administration

Struble

Division of Antiviral Drug Products

Food and Drug Administration

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring,

MD 20993 · 800-439-1420

March 16, 2011