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FDA Approves TB Drug Despite Some Concerns

FDA Approves TB Drug Despite Some Concerns [the Philadelphia Inquirer]

From Philadelphia Inquirer (PA) (January 1, 2013)

Jan. 01--Tuberculosis remains enough of a worldwide scourge, especially for adult patients in developing countries who have tried other medications, that the U.S. Food and Drug Administration said Monday that it gave fast-track approval to a new drug, despite safety concerns about it during testing.

Janssen Therapeutics, which is based in Titusville, N.J., and is part of health-care giant Johnson & Johnson, got approval for the drug bedaquiline, which will have the brand name Sirturo.

The FDA approved it even though Janssen has not completed the normal three phases of clinical trials and in one trial, "nine patients who received Sirturo died compared with two patients who received placebo," according to the FDA statement.

"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," Edward Cox, director of the FDA’s office of antimicrobial products in the Center for Drug Evaluation and Research, said in a statement.

"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."

Tuberculosis, which usually passes through the air and attacks the lungs, can be fatal. The Centers for Disease Control and Prevention said the United States had 10,528 cases of all forms in 2011, the lowest since national reporting began in 1953, with 98 cases being multidrug resistant. But the World Health Organization said there were 8.7 million new cases of TB in 2011, with 630,000 people having multidrug-resistant TB.

Sirturo works by inhibiting an enzyme that is involved in generating tuberculosis.

"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," Paul Stoffels, of J&J, said in a statement.


Contact staff writer David Sell at dsell@ or 215-854-4506. Read his blog at and on Twitter @phillypharma.


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Posted: January 2013