FDA Approves New TB Drug

Sirturo is the first drug approved to treat multi-drug resistant TB. It works by inhibiting an enzyme needed by M. tuberculosis to replicate and spread throughout the body.

The U.S. Food and Drug Administration announced Dec. 31 it has approved Sirturo (bedaquiline) as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis when alternatives are not available.

TB is an infection caused by Mycobacterium tuberculosis; CDC reports nearly 9 million people around the world and 10,528 people in the United States became sick with TB during 2011. Multi-drug resistant TB occurs when M. tuberculosis becomes resistant to isonazid and rifampin, the drugs most commonly used to treat TB. Sirturo is the first drug approved to treat multi-drug resistant TB and works by inhibiting an enzyme needed by M. tuberculosis to replicate and spread throughout the body.

"Multi-drug resistant tuberculosis poses a serious health threat throughout the world, and Sirturo provides much-needed treatment for patients who have don't have other therapeutic options available," said Edward Cox, M.D., MPH, director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. "However, because the drug also carries some significant risks, doctors should make sure they use it appropriately and only in patients who don't have other treatment options."

Sirturo is being approved under FDA's accelerated approval program, which allows for earlier access to promising new drugs while the companies conduct additional studies to confirm their clinical benefit and safe use. FDA also granted Sirturo fast track designation, priority review, and orphan-product designation. "The drug demonstrated the potential to fill an unmet medical need, has the potential to provide safe and effective treatment where no satisfactory alternative therapy exists, and is intended to treat a rare disease, respectively," according to the agency's news release.

Sirturo's manufacturer, Janssen Therapeutics, is a division of Janssen Products LP and is based in Titusville, N.J.

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