FDA grants priority review to TB drug

September 5, 2012

FDA has granted priority review to bedaquiline, or TMC207 (Johnson & Johnson's Janssen Research & Development), for treatment of multidrug-resistant tuberculosis.

FDA has granted priority review to bedaquiline, or TMC207 (Johnson & Johnson's Janssen Research & Development), for treatment of multidrug-resistant tuberculosis (TB). Bedaquiline would be the first drug specifically indicated for multidrug-resistant TB, and the first new type of TB drug in more than 4 decades.

On June 29, the drug maker applied for approval to market bedaquiline as part of combination therapy for adults with multidrug-resistant TB lung infections.

Under a priority review, FDA aims to decide whether to approve drugs within 6 months of the application's submission, rather than the standard 10 months.

About 1.4 million people worldwide die from TB each year, about 10% 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.