Janssen Therapeutics has obtained accelerated approval from FDA for Sirturo (bedaquiline) tablets as part of combination therapy to treat adult patients with pulmonary multi-drug resistant tuberculosis (MDR-TB).
The surrogate endpoint of time to sputum culture conversion in the TMC207-C208 Study 1 and Study 2 is the basis for the accelerated approval of the diarylquinoline antimycobacterial drug, Sirturo.
Johnson & Johnson pharmaceuticals chief scientific officer and worldwide chairman Paul Stoffels said Sirturo is the first TB therapy to receive accelerated approval 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," Dr. Stoffels added.
Sirturo should be administered by directly observed therapy.
The drug works by inhibiting mycobacterial adenosine 5' triphosphate (ATP) synthase, a key enzyme involved in energy production in Mycobacterium tuberculosis.