Breaking News, Trials & Filings

Tibotec’s HIV Drug Granted Priority Review

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

Tibotec Pharmaceuticals Ltd.’s NDA for TMC114, an investigational HIV protease inhibitor, has been accepted for priority review by the FDA. The goal date for the NDA will be June 23, 2006. The NDA is based on the efficacy and safety results of the 24-week analysis of two randomized, controlled studies, POWER 1 and POWER 2, and supportive open label safety data from POWER 3. Phase III trials of TMC114, boosted with low-dose ritonavir, are currently ongoing in both treatment-experienced...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters