Johnson & Johnson Receives FDA and EC Approval for SIRTURO® (bedaquiline)

Johnson & Johnson has received full approval from the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for SIRTURO® (bedaquiline), marking a significant milestone in tuberculosis (TB) treatment.

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Highlights

The FDA has granted traditional approval for SIRTURO® as part of combination therapy in adult and pediatric patients with pulmonary TB resistant to rifampicin and isoniazid, removing previous label restrictions from its accelerated approval in 2012. The EC has converted its Conditional Marketing Authorisation to a Standard Marketing Authorisation, following positive assessments by regulatory bodies.

Phase 3 Study Support

The approvals are backed by Phase 3 STREAM Stage 2 study results (NCT02409290), demonstrating superior treatment outcomes with a bedaquiline-containing regimen compared to injectable-containing regimens. Published in The Lancet, these findings underscore the efficacy and safety of all-oral treatment options for multidrug-resistant TB.