FDA’s Anti-Infective Drugs Advisory Committee wants tighter subject recruiting standards and additional subgroup data to emerge from a planned confirmatory trial of Janssen Pharmaceutical Cos.’ tuberculosis drug Sirturo (bedaquiline), to which the panel recommended FDA grant accelerated approval.
If approved, Sirturo will be the first drug with a new mechanism of action to treat tuberculosis in more than 40 years, and the first of a new crop of...