Janssen Therapeutics announced that the FDA has granted accelerated approval to Sirturo (bedaquiline tablets) for the treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB) as part of combination therapy in adults. Sirturo is a diarylquinolone antimycobacterial drug that inhibits mycobacterial ATP synthase, an enzyme essential for the generation of energy in Mycobacterium tuberculosis. Sirturo is the first TB approval with a new mechanism in 40 years.
The accelerated approval is based on data from TMC207-C208 Study 1 and Study 2. The primary endpoint was time to sputum culture conversion, defined as 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.
Sirturo will only be available through a single supplier in 100mg dosage strength tablets in 188-count bottles.
For more information call (800) JANSSEN or visit www.janssentherapeutics.com/.