German Drug Maker Boehringer Ingelheim Applies for U.S., E.U. Approval of Antiretroviral Drug Tipranavir
German drug maker Boehringer Ingelheim has applied for U.S. and E.U. approval to sell and market its antiretroviral drug tipranavir, the company announced on Monday, Reuters reports. The drug is a protease inhibitor meant for use by HIV-positive people for whom other antiretroviral drugs have been unsuccessful. The company is seeking accelerated evaluation in Europe and priority review from FDA, which could result in a decision in as few as six months. A company spokesperson said that the drug could be available as early as the middle of 2005. If approved, the drug could rival drugs manufactured by Roche and GlaxoSmithKline that are intended for HIV-positive people with drug-resistant strains of the virus, according to Reuters (Shankar, Reuters, 10/25).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.