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Boehringer Ingelheim Aptivus To Get FDA Advisory Committee Review In May

This article was originally published in The Pink Sheet Daily

Executive Summary

Tipranavir will be considered by FDA's Antiviral Drugs Advisory Committee for the treatment of patients with multi-drug-resistant HIV. In clinical trials, use of the protease inhibitor was associated with GI adverse events and elevated triglycerides.

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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.

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.

Boehringer Ingelheim Tipranavir NDA Could Signal Novel HIV Salvage Option

Non-peptidic protease inhibitor is “potent new treatment” for multi-drug-resistant HIV strains, firm says. NDA seeks accelerated approval and priority review for treatment of HIV-1 in combination with antiretrovirals in PI-experienced patients.

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