BioCentury
ARTICLE | Clinical News

Sirturo bedaquiline regulatory update

January 7, 2013 8:00 AM UTC

On Dec. 28, 2012, FDA granted accelerated approval to an NDA from Johnson & Johnson for Sirturo bedaquiline to treat adults with multi-drug resistant pulmonary tuberculosis (TB) 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 next quarter. 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 >=6 months after all treatment is completed. J&J said the trial is slated to begin this year and is expected to take about 5 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 (see BioCentury, Dec. 3, 2012). ...