FDA staffers seem to back safety of Janssen bedaquiline (Sirturo)

Ahead of the November 28 meeting of the US Food and Drug Administration’s Anti-Infective Drugs Advisory Committee to review bedaquiline, an experimental drug being developed by Janssen Research and Development, a unit of US health care giant Johnson & Johnson (NYSE: JNJ), briefing papers to expert reviewer suggest that the agency staff see the drug as appearing "safe and well-tolerated."

The company is seeking accelerated approval of bedaquiline – proposed trade name Sirturo - to treat pulmonary multi- drug-resistant tuberculosis (MDR-TB) patients as part of combination therapy for adults. Accelerated approval means that a decision could be based on Phase II clinical data. Priority review was granted by the agency in September, when the company also applied for European approval (The Pharma Letter September 2).

The briefing papers also indicate that, although the current data support the oral compound's safety, the highest dose of the drug does have the potential to affect the heart's rhythm.