The U.S. Food and Drug Administration (FDA) has issued traditional approval for Johnson & Johnson’s SIRTURO (bedaquiline) as part of combination therapy in adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid.
With the FDA’s approval, label restrictions that were included when the medicine was granted accelerated approval in the U.S. in December 2012 are removed.
The European Commission (EC) has also granted full approval of SIRTURO, converting its Conditional Marketing Authorisation to a Standard Marketing Authorisation, following a positive opinion in April 2024 from the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The approvals were supported by results from the Phase 3 STREAM Stage 2 study, 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.
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.
