FDA sets priority review for J& tuberculosis drug
NEW BRUNSWICK, N.J. (AP) — Johnson & Johnson said Wednesday that the U.S. Food and Drug Administration will give a priority review to its experimental treatment for multidrug-resistant tuberculosis.
J&J's Janssen Research & Development unit on June 29 applied for approval to market bedaquiline, or TMC207, as part of combination therapy for adults with multidrug-resistant tuberculosis lung infections.
Under a priority review, the FDA aims to decide whether to approve drugs within six months of the application's submission, rather than the standard 10 months, because they may offer a major advance or treat a condition with few or no therapies. Bedaquiline would be the first drug specifically for multidrug-resistant tuberculosis, and the first new type of TB drug in more than four decades.
About 1.4 million people worldwide die from tuberculosis each year, roughly 10 percent of them from forms resistant to at least two of the standard drugs for the deadly bacterial disease.
J&J applied for approval to market the drug in the European Union on Aug. 31.
In late-morning trading, J&J shares were up 26 cents at $67.52.