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.
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Aptivus Labeling Recommends Genotypic And Liver Function Testing
Labeling for Boehringer Ingelheim's HIV therapy recommends genotypic or phenotypic testing and liver function testing prior to therapy. Aptivus (tipranavir) clears FDA with a "black box" warning on hepatitis and hepatic decompensation and extensive drug-drug interactions.
Aptivus Labeling Recommends Genotypic And Liver Function Testing
Labeling for Boehringer Ingelheim's HIV therapy recommends genotypic or phenotypic testing and liver function testing prior to therapy. Aptivus (tipranavir) clears FDA with a "black box" warning on hepatitis and hepatic decompensation and extensive drug-drug interactions.
Aptivus "Suboptimal" Comparator Arm Likely Key Issue For Antivirals Cmte.
The majority of comparator patients in the pivotal RESIST trials were resistant to their assigned agent, FDA says. The agency's reanalysis of the trials, however, continues to show statistical significance for tipranavir. Safety issues for Boehringer Ingelheim's HIV drug include hepatotoxicity and drug-drug interactions.