Aptivus Needs Further Studies To Guide Use After Accelerated Approval, Cmte. Says
This article was originally published in The Pink Sheet Daily
Executive Summary
More information is needed on appropriate HIV patient populations and how to manage adverse events, FDA's Antiviral Drugs Advisory Committee says. Accelerated approval is recommended by 11-to-3 vote for use of Boehringer Ingelheim's tipranavir in heavily pre-treated patients.