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.
"The number of treatment-experienced HIV-infected patients in the U.S. continues to grow," said Dr. Kathleen Squires, Associate Professor of Medicine at the Keck School of Medicine at the University of Southern California and Medical Director at the Rand Schrader Clinic of the LAC + USC Medical Center. "Tipranavir may offer an important option for those who need new therapy to stay ahead of HIV drug resistance."
Tipranavir Tipranavir is a non-peptidic protease inhibitor currently in late Phase 3 clinical development -- the final stage of testing prior to the submission of data to the FDA for review for marketing approval. Tipranavir is also being evaluated for use in pediatric and treatment-naove patient populations in Phase 2 and 3 studies that are currently underway. The investigational drug, tipranavir, does not cure HIV infection/AIDS or prevent transmission of HIV to others.