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FDA Advisory Committee Recommends Approval of Tipranavir for Treatment of HIV

Strategic Insights

— 2 min read

The U.S. Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee has recommended the approval of the investigational anti-HIV drug tipranavir, a nonpeptidic protease inhibitor that requires boosting with low-dose ritonavir and must be used in combination with other antiretroviral agents. The committee's positive recommendation is based on data from two large, well-controlled phase III clinical trials, RESIST-1 and RESIST-2, which examined the treatment response of tipranavir boosted with ritonavir (tipranavir/r) versus a comparator group. The committee's recommendations will be considered by the FDA in its review of the new drug application submitted by Boehringer Ingelheim.

Key Takeaways:

  • The FDA Antiviral Drugs Advisory Committee has recommended the approval of tipranavir, a nonpeptidic protease inhibitor, for the treatment of HIV.
  • The recommendation is based on data from two large, well-controlled phase III clinical trials, RESIST-1 and RESIST-2.
  • Tipranavir requires boosting with low-dose ritonavir and must be used in combination with other antiretroviral agents to be effective.
  • The committee's recommendation is a positive step towards the potential approval of tipranavir, but the FDA is not bound by the committee's recommendation and will review the application independently.
  • Boehringer Ingelheim will continue to provide tipranavir to eligible patients through a compassionate use program prior to its commercial availability.
  • Tipranavir has shown activity against many strains of HIV-1 that are resistant to commercially available protease inhibitors, based on available clinical and in vitro data.
  • Ongoing studies are evaluating the use of tipranavir/r in pediatric and treatment-naive patient populations.
  • Boehringer Ingelheim submitted a priority, 6-month review new drug application for tipranavir to the FDA in late 2004.

Statistics:

  • Two large, well-controlled phase III clinical trials, RESIST-1 and RESIST-2, were conducted in protease inhibitor (PI)-resistant treatment-experienced patients.
  • A total of 599 patients were enrolled in the RESIST-1 and RESIST-2 trials.
  • The trials examined the treatment response of tipranavir boosted with ritonavir (tipranavir/r) versus a comparator group in patients with HIV-1 resistance to commercially available protease inhibitors.
  • Tipranavir/r has shown activity against many strains of HIV-1 that are resistant to commercially available protease inhibitors, based on available clinical and in vitro data.
  • The compassionate use program will continue to provide tipranavir to eligible patients prior to its commercial availability.

Sources:

  • Health & Medicine Week editors
  • Boehringer Ingelheim Pharmaceuticals, Inc.
  • U.S. Food and Drug Administration (FDA)
  • NewsRx.com
  • Health & Medicine Week (Copyright 2005)

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