Boehringer Ingelheim has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tipranavir.
The Company is seeking accelerated approval of tipranavir and has requested a priority, six-month review of the NDA. Priority review designation is based upon whether a drug provides a significant improvement in the treatment of a serious or life-threatening disease. Tipranavir is a non-peptidic protease inhibitor under investigation for the treatment of HIV-1 infection in combination with other antiretroviral agents.
"Boehringer Ingelheim has worked diligently to develop tipranavir as quickly as possible in response to the urgent need for new therapies for treatment-experienced HIV-positive patients," said Paul Fonteyne, Executive Vice President and Head of Sales & Marketing at Boehringer Ingelheim Pharmaceuticals, Inc.
Two large-scale Phase 3 clinical trials, RESIST-1 and RESIST-2,1 form the foundation of the NDA for tipranavir. These studies are randomized, controlled, open-label trials designed to examine the safety and efficacy of tipranavir, boosted with low-dose ritonavir (tipranavir/r), versus a low-dose ritonavir-boosted comparator protease inhibitor in treatment-experienced patients. Interim data from RESIST-1 will be presented at the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington, DC on October 31.