Important note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date. |
AIDS TREATMENT NEWS - April 8, 2005
John S. James
Summary: At a one-day public meeting in Gaithersburg, Maryland (near Washington D.C.), the FDA will hear from experts and members of the public on tipranavir, an important new protease inhibitor expected to be approved soon.
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:
Note: For recent general information about tipranavir, see the four abstracts from the 12th Retroviruses Conference, February 2005:
| 1. | J Schapiro, P Cahn, B Trottier, et al., "Effect of Baseline Genotype on Response to Tipranavir/ritonavir (TPV/r) Compared with Standard-of-care Comparator (CPI/r) in Treatment-experienced Patients: The Phase 3 RESIST-1 and -2 Trials" Conf Retroviruses Opportunistic Infect. 2005 Feb 22-25;12th: Abstract No. 104. |
| 2. | D Cooper, C Hicks, P Cahn, et al., "24-Week RESIST Study Analyses: the Efficacy of Tipranavir/Ritonavir Is Superior to Lopinavir/Ritonavir, and the TPV/r Treatment Response is Enhanced by Inclusion of Genotypically Active Antiretrovirals in the Optimized Background Regimen" Conf Retroviruses Opportunistic Infect. 2005 Feb 22-25;12th: Abstract No. 560. |
| 3. | Albert Wu, I C Huang, F Lobo, et al. "Health-related Quality of Life with Tipranavir in Combination with an Optimized Background Regimen in 2 Randomized Clinical Trials" Conf Retroviruses Opportunistic Infect. 2005 Feb 22-25;12th: Abstract No. 617. |
| 4. | Chan-Loi Yong, J Sabo, C Oksala, et al., "Population Pharmacokinetic Assessment of Systemic Steady-state Tipranavir Concentrations for Adults Administered Tipranavir/Ritonavir 500/200 mg Twice Daily" Conf Retroviruses Opportunistic Infect. 2005 Feb 22-25;12th: Abstract No. 654. |
They can also be found through the abstract search at http://www.retroconference.org/Search_Abstract_2005/ Type in 'tipranavir' (without the quotation marks), make sure that 'Abstract Title' is selected, and click 'Find!'.
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