FDA Sets Johnson & Johnson's TB Drug on Accelerated Path to Approval
Published: Sep 07, 2012
Johnson & Johnson said 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.