Boehringer Ingelheim today announced that the U.S. Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee recommended the approval of the investigational anti-HIV drug tipranavir (11-3). Tipranavir is a non-peptidic protease inhibitor that requires boosting with low-dose ritonavir and must be used in combination with other antiretroviral agents.
"We are pleased with the committee's recommendation and commend its thorough discussion of the tipranavir clinical data," said Dr. Andreas Barner, Member of the Board of Managing Directors of Boehringer Ingelheim, responsible for Research, Development and Medicine. "We look forward to soon being able to offer patients in need a new, efficacious treatment alternative."
The committee's positive recommendation is based on data from two large, well-controlled Phase 3 clinical trials, RESIST-1 and RESIST-2, conducted in protease inhibitor (PI)-resistant treatment-experienced patients. These patients had taken three classes of anti-HIV drugs and were failing their PI-based regimen at the time of study entry. These trials examine the treatment response of tipranavir boosted with ritonavir (TPV/r) versus a comparator group in which patients received one of several marketed ritonavir-boosted PIs. In addition, patients in both arms received an optimized background regimen of other antiretroviral drugs.
The committee's recommendations will be considered by the FDA in its review of the New Drug Application that Boehringer Ingelheim submitted for tipranavir. The FDA is not bound by the committee's recommendation, but takes its advice into consideration when reviewing investigational drugs seeking approval.
Boehringer Ingelheim will continue to provide tipranavir to eligible patients prior to its commercial availability through a Compassionate Use Program, which is being run as an Expanded Access Program in the U.S.
Tipranavir is a non-peptidic protease inhibitor currently in late Phase 3 clinical development. Boehringer Ingelheim submitted a New Drug Application for tipranavir to the U.S. Food and Drug Administration in late 2004 that was granted a priority, six-month review in February 2005.
Based on available clinical and in vitro data, tipranavir/r appears to retain activity against many strains of HIV-1 that are resistant to commercially available protease inhibitors. These findings are currently being further evaluated in ongoing studies. Tipranavir/r is also being evaluated for use in pediatric and treatment-naive patient populations in Phase 2 and 3 studies that are currently underway.