Sirturo bedaquiline regulatory update

FDA's Anti-Infective Drugs Advisory Committee voted 18-0 that efficacy data for Sirturo bedaquiline from Johnson & Johnson supported accelerated approval to treat multi-drug-resistant tuberculosis. The panel voted 11-7 that J&J provided substantial safety data.

Panel members were concerned by the imbalance of deaths in the pivotal Phase II trial of bedaquiline (10 for bedaquiline vs. 2 for background treatment alone), but neither FDA nor J&J could identify a consistent cause of death linked to the antibiotic. Most panelists agreed the imbalance was likely to due to the small trial size (n=161). ...