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.
