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FDA approves Sirturo for pulmonary TB
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The FDA approved bedaquiline this week as part of combination therapy to treat adults with multi-drug resistant tuberculosis when other treatment options are unavailable. Bedaquiline was approved under the FDA’s accelerated approval program, which gives patients access to the drug while its maker, Janssen Therapeutics, conducts additional studies to confirm its safety and efficacy.
“Multi-drug resistant tuberculosis poses a serious health threat throughout the world, and Sirturo provides much-needed treatment for patients who don’t have other therapeutic options available, Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research, said in an FDA press 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.”
Edward Cox
Bedaquiline (Sirturo, Janssen Therapeutics) carries a boxed warning indicating that the drug could affect the heart’s electrical activity, which could result in a potentially fatal heart rhythm. The warning also indicates risk for death in patients treated with the drug. According to the FDA, nine patients treated with bedaquiline died vs. two patients who received placebo during clinical trials. Five of the deaths in the bedaquiline group and all of the deaths in the placebo arm of the study appeared related to TB, but researchers could not identify any consistent reasons for death in the remaining patients treated with bedaquiline.
Data from two phase-2 clinical trials evaluated bedaquiline in 440 patients with TB. Results from the first trial indicated that patients treated with bedaquiline combination therapy achieved sputum culture conversion in a median time of 83 days, compared with 125 days in patients assigned placebo. Results from the second trial indicated that the median time to culture conversion was 57 days in patients treated with bedaquiline. Common adverse events included nausea, joint pain and headache.
The FDA has also granted bedaquiline fast track designation, priority review and orphan-product designation. In clinical trials, bedaquiline 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 CDC, almost 9 million people worldwide and 10,528 people in the US developed TB in 2011.