Tipranavir is a non-peptidic protease inhibitor (PI) that requires boosting with low-dose ritonavir and must be used in combination with other antiretroviral agents.
The committee’s positive recommendation is based on data from two large, well-controlled phase III clinical trials conducted in PI-resistant treatment-experienced patients. 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.
The committee’s recommendations will be considered by the FDA in its review of the new drug application (NDA) 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 US.