JnJ gets USFDA, European Commission nod for Sirturo

The approvals were supported by results from the Phase 3 STREAM Stage 2 study (NCT02409290), the first large-scale, randomized, multi-country open-label clinical study to evaluate the efficacy and safety of an all-oral bedaquiline-containing regimen for treatment of MDR-TB. Results confirmed that a bedaquiline-containing regimen offered a significant improvement in treatment outcomes compared to injectable-containing regimens. Findings from the study were published in The Lancet in November 2022.

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SIRTURO was granted accelerated approval by the FDA in December 2012 and conditional approval by the EMA in March 2014 following positive Phase 2 study data. A supplemental New Drug Application was submitted to the FDA in August 2023 to support the transition to full approval in the U.S. in addition to a Type II variation filed with the European Medicines Agency (EMA) in November 2023 to support the transition to Standard Marketing Authorisation.