Food and Drug Administration - July 18, 2007
Richard Klein & Kimberly Struble

The purpose of the meeting is to discuss new drug application (NDA) 22-145 for the new drug raltegravir potassium, integrase inhibitor, 400 milligram tablets, Merck & Co., Inc., for the treatment of Human Immunodeficiency Virus-1 (HIV-1) infection, in combination with other antiretroviral agents, in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. Raltegravir works by blocking an HIV enzyme called integrase, which is one of the three enzymes necessary for HIV to replicate in the body. Raltegravir is the first drug of the new class called integrase inhibitors to be considered for approval.

Interested members of the public are encouraged to present data, information or views - orally or in writing û related to the application pending before the committee. Written submissions may be made to the contact person (see below) on or before August 21, 2007.

Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those desiring to make formal oral presentations should notify the contact person 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 August 14, 2007.

Time allotted for each presentation may be limited, depending on the number of requests to speak. 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 August 13, 2007.

FDA intends to make background material available to the public at least 2 business days before the meeting at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. Click on the year 2007, and scroll down to the appropriate advisory committee link to find the information.

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.

Contact Person: Cicely Reese, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: Cicely.Reese@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512531.

Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

Those attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings. There is no registration and no fee required to attend.

FDA will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Cicely Reese at least 7 days in advance of the meeting.

For directions or lodging information, please contact the hotel directly at 301-589-5200.

Richard Klein | Office of Special Health Issues | Food and Drug Administration

Kimberly Struble | Division of Antiviral Drug Products | Food and Drug Administration
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SOURCE: Food and Drug Administration (FDA).

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