A US Food and Drug Administration advisory panel recommended that Boehringer Ingelheim’s investigational anti-HIV drug, Aptivus (tipranavir), be approved, but called for further studies “to guide use of the drug.”
Although the panel voted 11 to three in favour of recommending accelerated approval for the drug, agreeing that efficacy had been demonstrated, it said that the exact usefulness needed to be monitored in the future. It also called for additional information on how to monitor and manage adverse events, as well as greater clarity on which patients are most likely to respond to the product. Studying long-term liver toxicity should be a priority, the panelists said. Liver toxicity was observed in 6% of Aptivus patients participating in pivotal trials, compared to 2% of patients receiving active control.
BI originally filed the drug with the FDA back in October last year with a dossier including data from two Phase III clinical studies – RESIST-1 and RESIST-2.1 – which evaluated tipranavir plus Abbott’s Norvir (ritonavir) versus a protease inhibitor regimen in treatment experienced HIV patients [[26/10/04f]]. The company is currently conducting an extended follow-up of the two trials, as well as trials in treatment-naïve HIV patients and paediatric patients.