FDA approves bedaquiline

FDA granted accelerated approval on Friday to an NDA from Johnson & Johnson (NYSE:JNJ) for Sirturo bedaquiline ( TMC207) to treat adults with multi-drug resistant pulmonary tuberculosis as part of a combination therapy when other alternatives are not available. The drug's label includes a boxed warning about an increased risk of death and QT/QTc interval prolongation. J&J said it will disclose the price when it launches the diarylquinoline (DARQ) antibiotic that inhibits mycobacterial F1F0-ATP synthase in 2Q13. The pharma said Sirturo is the first TB therapy with a new mechanism of action to be approved in 40 years.

Sirturo's approval is based on data from the Phase II TMC207-C208 program which showed that Sirturo met the surrogate endpoint of sputum culture conversion vs. placebo. As part of the approval, J&J is required to conduct a confirmatory Phase III trial of Sirturo to assess the long-term outcomes of failure, relapse or death at least six months after all treatment is completed. J&J said the trial is slated to begin this year and is expected to take about five years to complete. The pharma said it is working with FDA to finalize specific details of the trial, including the primary endpoint and number of patients. ...