BioCentury
ARTICLE | Company News

FDA releases bedaquiline briefing docs

November 27, 2012 1:08 AM UTC

FDA's Anti-Infective Drugs Advisory Committee will discuss on Wednesday whether safety and efficacy data support accelerated approval of Sirturo bedaquiline from Johnson & Johnson (NYSE:JNJ) to treat multi-drug-resistant tuberculosis (TB). In briefing documents released ahead of the meeting, agency reviewers said 400 mg daily bedaquiline significantly reduced the time to sputum culture conversion at 8 weeks vs. placebo, the primary endpoint in the first stage of the Phase IIb TMC207-C208 trial. The reviewers also said time to sputum culture conversion was "faster and was seen more frequently" with bedaquiline vs. placebo in the second stage of the trial.

On safety, FDA reviewers said bedaquiline is "safe and well-tolerated." The reviewers did say increases in the QT interval attributed to the 400 mg dose of bedaquiline "should be noted" but said a thorough QT trial showed no significant QTc prolongation associated with the molecule. ...