Sirturo Approved for Multi-Drug Resistant TB
WEDNESDAY, Jan. 2 -- Sirturo (bedaquiline) has been approved by the U.S. Food and Drug Administration for use with other drugs to treat multi-drug resistant tuberculosis when alternative treatments aren't available.
TB, which is spread through the air, is among the world's deadliest respiratory diseases. Nearly 9 million people worldwide and more than 10,000 in the United States contracted the disease in 2011, the agency said in a news release.
The bacterium that causes TB, M. tuberculosis, has become resistant to the powerful drugs isoniazid and rifampin, the FDA added.
Sirturo is the first drug approved to treat multi-drug resistant TB, the agency said in its news release. The drug inhibits an enzyme that makes it possible for the tuberculosis bacterium to replicate 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," Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in the news release. "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 carries a boxed label warning of the possibility of a potentially fatal heart rhythm disorder.
The drug's safety and effectiveness were established in clinical trials involving 440 people. Common side effects included nausea, joint pain and headache.
Sirturo is produced by Janssen Products LP, based in Titusville, N.J.
The U.S. Centers for Disease Control and Prevention has more about tuberculosis.
Posted: January 2013