Tipranavir, Boehringer-Ingleheim’s investigational protease inhibitor, has cleared a key hurdle on the path to formal approval in Europe.
On July 28th, the Committee for Medicinal Products for Human Use issued a positive opinion for tipranavir. This positive opinion is viewed as a recommendation to the European Commission that authorisation to market the drug in the European Union should be granted.
Accelerated approval of tipranavir was granted in the United States in June under the tradename Aptivus, which will also be the drug’s tradename in Europe. The European marketing approval is expected to be be granted in late 2005.
Tipranavir is indicated for use in HIV-positive individuals with extensive experience of antiretroviral therapy and who are resistant to other protease inhibitors.