In a significant development for the treatment of drug-resistant tuberculosis (TB), Johnson & Johnson has announced that SIRTURO (bedaquiline) has received full approval from the U.S. Food and Drug Administration (FDA) and the European Commission (EC). This approval marks a pivotal milestone in the fight against pulmonary TB that is resistant to standard treatments like rifampin and isoniazid. The drug, suitable for adults and pediatric patients aged 5 years and above and weighing at least 15 kilograms, now moves beyond the label restrictions imposed during its accelerated approval phase in December 2012.

The FDA’s traditional approval was supported by robust data from the Phase 3 STREAM Stage 2 study (NCT02409290), a comprehensive, multi-country clinical trial evaluating the efficacy and safety of an all-oral bedaquiline-containing regimen. This study, published in The Lancet in November 2022, demonstrated that the bedaquiline regimen significantly improved treatment outcomes compared to older, injectable-containing regimens. The European Medicines Agency (EMA) echoed this sentiment, converting SIRTURO’s Conditional Marketing Authorization to a Standard Marketing Authorization, following a positive assessment by the European Committee for Medicinal Products for Human Use (CHMP) in April 2024.

SIRTURO initially received accelerated approval from the FDA in December 2012 and conditional approval from the EMA in March 2014 based on promising results from earlier phase 2 studies. Subsequent applications, including a supplemental New Drug Application in August 2023 to the FDA and a Type II variation to the EMA in November 2023, were pivotal in transitioning to full approval status.

This advancement is crucial as TB remains one of the world’s deadliest infectious diseases, particularly its drug-resistant forms. SIRTURO’s full approval not only enhances the treatment arsenal against TB but also highlights the importance of continuing innovation in the pharmaceutical industry to address global health challenges.

The full approval of SIRTURO by the FDA and EC is a testament to the drug’s efficacy and safety, established over a decade of clinical research and trials. It underscores the shift towards more effective and less invasive treatment regimens for serious infectious diseases like TB. Patients now have access to a therapy that is not only more effective but also easier to administer, potentially improving adherence and outcomes in long-term TB care.

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