FDA committee recommends approval of Aptivus

The Food and Drug Administration's Antiviral Drugs Advisory Committee on Thursday voted 11-3 to recommend the approval of Aptivus (tipranavir), an investigational HIV protease inhibitor developed by Boehringer Ingelheim. Aptivus is a nonpeptidic protease inhibitor that requires boosting with low-dose Norvir and must be used in combination with other antiretroviral agents. The committee's recommendations will be considered by the FDA in its review of the New Drug Application that Boehringer Ingelheim submitted for Aptivus. The FDA is not bound by the committee's recommendation but takes its advice into consideration when reviewing investigational drugs seeking approval. The FDA granted priority review status to Aptivus, which means a final marketing decision by the agency will be issued no later than August 2005. The committee's positive recommendation is based on data from two large Phase III clinical trials, conducted in protease inhibitor-resistant and treatment-experienced patients. Study subjects had taken three classes of anti-HIV drugs and were failing their protease inhibitor-based regimen at the time of study entry. The trials showed that a significant number of study subjects with resistance to other protease inhibitors responded well to Aptivus, reducing blood-based viral loads and posting improvements in CD4-cell counts.