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Further Studies Needed for Tipranavir
By FDA Advisory Committe,
May 20, 2005 - 8:26:38 AM
Boehringer Ingelheim's Aptivus should be approved for treatment resistant HIV patients, but further studies are needed to guide use of the drug, FDA's Antiviral Drugs Advisory Committee recommended May 19.
"We as a committee have agreed that we feel that there is efficacy demonstrated, but the exact usefulness needs to be monitored in the future," committee chair Janet Englund (University of Washington) said.
The panel voted 11 to 3 in favor of recommending accelerated approval for Aptivus (tipranavir).
Committee members emphasized that further data are necessary to understand how to appropriately use the agent.
The committee needs "guidance both from the company's future studies and from the FDA to be able to use the drug in the best possible way," Englund said.
Further information is needed on how to monitor and manage adverse events, as well as greater clarity on which patients are most likely to respond to tipranavir, committee members said.
Studying long-term liver toxicity should be a priority, committee members said. In pivotal trials, 6% of tipranavir patients exhibited grade 3/4 elevations in ALT/ALS liver enzymes, compared to 2% of patients receiving active control.
"I clearly would urge the pharmaceutical sponsor, since we know that there is this persistent elevation in liver function studies, to generate data that lets us know the baggage with elevation over time," committee member Lauren Wood (Uniformed Services University of Health Sciences) said.
Genotype data on patients likely to respond to Aptivus would also be useful, committee members said. An eight-week "�escape clause" in the Phase III trials made it difficult to isolate which patients responded to therapy.
BI is currently conducting an extended follow-up of the two pivotal trials, as well as trials in treatment-na've HIV patients and pediatric patients.
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