FDA Grants Accelerated Approval for SIRTURO™ (bedaquiline) as Part of Combination Therapy to Treat Adults with Pulmonary Multi-Drug Resistant Tuberculosis

Janssen Therapeutics, Division of Janssen Products, LP, today announced the U.S. Food and Drug Administration (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. The accelerated approval is based on the surrogate endpoint of time to sputum culture conversion. "SIRTURO™ was first discovered in our laboratories more than a decade ago and it is gratifying to see our discovery and development lead to the accelerated approval of the first TB therapy in 40 years with a new mechanism of action. This underscores our commitment as a company to discover, develop and responsibly deliver innovative medicines that address serious unmet medical needs," said Paul Stoffels, M.D., Chief Scientific Officer and Worldwide Chairman, Pharmaceuticals, Johnson & Johnson. SIRTURO™ inhibits mycobacterial ATP (adenosine 5'‑triphosphate) synthase, an enzyme that is essential for the generation of energy in Mycobacterium tuberculosis. SIRTURO™ is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adults (greater than or equal to 18 years) with pulmonary MDR-TB. Reserve SIRTURO™ for use when an effective treatment regimen cannot otherwise be provided. SIRTURO™ should be administered by directly observed therapy (DOT). This indication is based on analysis of time to sputum culture conversion from two controlled Phase 2 trials in patients with pulmonary MDR-TB. The safety and efficacy of SIRTURO™ for the treatment of latent infection due to Mycobacterium tuberculosis has not been established. The safety and efficacy of SIRTURO™ for the treatment of drug-sensitive TB has not been established. In addition, there are no data on the treatment with SIRTURO™ of extra-pulmonary TB (e.g., central nervous system). Therefore, use of SIRTURO™ in these settings is not recommended.