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FDA grants accelerated approval for Sirturo for multi-drug resistant TB

Wednesday, January 2, 2013

The FDA has granted accelerated approval to Janssen Therapeutics’ 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,” said Paul Stoffels, M.D., chief scientific officer and worldwide chairman of pharmaceuticals, Johnson & Johnson. “This underscores our commitment as a company to discover, develop and responsibly deliver innovative medicines that address serious unmet medical needs.”

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 (18 years old or older) with pulmonary MDR-TB.

MDR-TB is considered an orphan disease in the U.S., with 98 reported patients in 2011. MDR-TB is characterized by resistance to two of the most powerful medicines in today’s four-drug standard TB treatment regimen. MDR-TB treatment is complex and requires up to two years of treatment with companion drugs in accordance with national TB treatment guidelines and local MDR-TB treatment practice, along with extensive medical supervision. The World Health Organization (WHO) estimates more than two million people will develop MDR-TB between 2011 and 2015.

“This is the first time a new drug is being introduced specifically for MDR-TB, for which the current needs are so great,” said Lee Reichman, M.D., executive director, New Jersey Medical School Global Tuberculosis Institute. “It is an important step in the development of new compounds for this serious and contagious disease.”

The FDA accelerated approval of Sirturo was 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.

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