FDA Committee Sets Review Dates for HCV Drugs Boceprevir and Telaprevir

	SUMMARY: The U.S. Food and Drug Administration (FDA) announced this week that the its Antiviral Drugs Advisory Committee will meet at the end of April to review data on the first eagerly awaited hepatitis C virus (HCV) protease inhibitors, Merck's boceprevir and Vertex Pharmaceuticals' telaprevir; the public is invited to attend and give their comments. The committee is expected to give a recommendation in late May, setting the stage for a full FDA approval decision this summer.

Below is an announcement from the FDA providing details about the forthcoming hearings.

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, 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 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

Paul 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: Paul.Tran@fda.hhs.gov

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 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 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 outlets.