Janssen Therapeutics, Division of Janssen Products, has received accelerated approval for Sirturo (bedaquiline) tablets from the US FDA to treat adult pulmonary multi-drug resistant tuberculosis (MDR-TB) patients.
The approval of Sirturo as part of combination therapy is based on the surrogate endpoint of time to sputum culture conversion.
Johnson & Johnson pharmaceuticals chief scientific officer and worldwide chairman Dr Paul Stoffels said that Sirturo is the first TB therapy in 40 years with a new mechanism of action.
"The accelerated approval of SIRTURO is a significant step in the fight against MDR-TB, which is a more difficult to treat form of TB that affects approximately 630,000 people in the world and is on the rise in many areas worldwide," Stoffels said.
The diarylquinoline antimycobacterial drug should be administered by directly observed therapy.
The indication is based on analysis of time to sputum culture conversion from two Phase II trials, TMC207-C208 Study 1 and Study 2, conducted in patients with pulmonary MDR-TB.
Sirturo was developed to inhibit mycobacterial adenosine 5′ triphosphate synthase enzyme, which is key for energy production in Mycobacterium tuberculosis.
New Jersey Medical School Global Tuberculosis Institute executive director Dr Lee Reichman said; "This is the first time a new drug is being introduced specifically for MDR-TB, for which the current needs are so great."
The safety and efficacy of Sirturo for the treatment of latent infection due to Mycobacterium tuberculosis, for the treatment of drug-sensitive TB were not been established.