For the first time in four decades, a new treatment for tuberculosis has been approved by the FDA, getting the nod on the last day of the year.
The agency said Sirturo (bedaquiline) from Johnson & Johnson's ($JNJ) Janssen Therapeutics unit was approved for use in patients with "multidrug resistant pulmonary tuberculosis (TB) when other alternatives are not available." The new drug does come with a boxed warning saying the drug can cause potentially fatal abnormal heart rhythms. But with standard drugs becoming less effective in more cases against the contagious and deadly disease, the agency gave the drug fast-track designation, priority review and orphan-product designation.
"Multidrug 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," said Edward Cox, director of the FDA's Office of Antimicrobial Products.
While many countries vaccinate for TB, it remains a widespread problem. The FDA said nearly 9 million people worldwide and more than 10,500 in the U.S. contracted TB last year. Bloomberg said there were about 400,000 cases of multidrug-resistant tuberculosis in 2011. Those were mostly in China, India, the Russian Federation and South Africa. Getting FDA approval will expedite approvals for the drug in other parts of the world where the disease is more prevalent and which use FDA and European Union approvals as references, Paul Stoffels, chief science officer at J&J, told Bloomberg.
One of the financial benefits of the program under which Johnson & Johnson developed the drug for a "neglected disease," Bloomberg points out, is that it gets a voucher for an expedited review of another drug. Stoffels said the company has not yet decided what new product it will ask to use that on.
- here's the FDA announcement
- here's the Johnson & Johnson release
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