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Tipranavir: FDA Advisory Committee will meet may 19, hear experts, public comment.

On April 4 the FDA announced a one-day meeting of its Antiviral Drugs Advisory Committee on the important new protease inhibitor tipranavir, which is widely expected to be approved soon. The FDA usually schedules these hearings when it when it wants outside advice either on whether to approve a drug, or on other questions such as safety issues, or what the company can claim as approved uses. We do not yet (April 5) know what questions the FDA plans to ask the committee; there should not be any big surprises, as we would have heard about them already through the trials. But in any case the advisory committee meetings usually provide the public with the most important and complete information available about the drug being considered.

Tipranavir, made by Boehringer Ingelheim, is important because it has a different resistance profile than currently approved protease inhibitors, so those who are already resistant to the existing drugs can benefit from it. In tests so far, those who started tipranavir were more likely to control resistant virus if they also started FUZEON (enfuvirtide, T-20) at the same time, so that they had two new drugs to which they were not resistant.

The FDA meeting will be Thursday, May 19, 2005 from 8 a.m. to 5 p.m. at the Hilton Washington DC/North in Gaithersburg, Maryland, salons A, B, and C. To get to the hotel from Washington, take the Metro Red Line to Shady Grove (the end of the line), and call the hotel for a shuttle, 301-977-8900.

Public comments are scheduled from 1 to 2 p.m.; those wanting to speak should give notice by May 6. Comments can also be submitted in writing, and should be received by May 6.

Detailed background information and meeting material will be available on the FDA's Web site at least 24 hours before the meeting.

For more information see 12531d051905.html

Note: For recent general information about tipranavir, see the four abstracts from the 12th Retroviruses Conference, February 2005, that mention 'tipranavir' in their title. These can be found through the abstract search at Type in 'tipranavir' (without the quotation marks), make sure that 'Abstract Title' is selected, and click 'Find!'.
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Publication:AIDS Treatment News
Geographic Code:1USA
Date:Feb 25, 2005
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