Sirturo bedaquiline regulatory update
The European Commission granted conditional approval to an MAA from Johnson & Johnson for Sirturo bedaquiline to treat pulmonary multidrug-resistant tuberculosis (MDR-TB) in adults. The approval covers use of bedaquiline as part of a combination therapy when alternative treatments cannot be used due to resistance or intolerance. Bedaquiline also has accelerated approval from FDA for pulmonary MDR-TB as part of a combination therapy when other alternatives are not available (see BioCentury, Jan. 7, 2013).
As part of both the conditional and accelerated approval, J&J plans to conduct a confirmatory Phase III trial of Sirturo that the pharma said will satisfy postapproval commitments from both agencies. The pharma said the protocol for the trial is still being finalized, but said the trial is slated to start this year. ...