FDA approves Sirturo (Janssen Therapeutics) for multi-drug resistant Tuberculosis

The FDA has granted accelerated approval to Sirturo (bedaquiline), from Janssen Therapeutics, for the treatment of pulmonary multi-drug resistant Tuberculosis (MDR-TB) as part of combination therapy in adults. The FDA accelerated approval is based on Phase II data from TMC207-C208 Study 1 and Study 2.

The primary endpoint was time to sputum culture conversion: the interval in days between the first dose of study drug and the date of the first of two consecutive negative sputum cultures collected at least 25 days apart during treatment. In Study 1, 70.1% of patients on Sirturo reached treatment success vs. 56.1% of patients on placebo. In addition, 29.9% of patients on Sirturo experienced treatment failure vs. 43.9% on placebo. In Study 2, the Sirturo group had a decreased time to culture conversion and improved culture conversion rates compared to placebo.