Johnson & Johnson (J&J) has received approvals from both the US Food and Drug Administration (FDA) and the European Commission (EC) for Sirturo (bedaquiline) to treat multidrug-resistant pulmonary tuberculosis (MDR-TB).
SIRTURO has been approved for use in combination therapy for adults and paediatric patients aged five years and older, weighing at least 15kg with TB caused by Mycobacterium tuberculosis resistant to rifampicin and isoniazid.
Johnson & Johnson filed the supplemental new drug application for the drug with the FDA in August 2023 for full approval in the US.
Following the FDA traditional approval, the label restrictions imposed when Sirturo received accelerated approval in the US in December 2012 have been removed.
On the other hand, the EC has granted full approval to Sirturo, converting its conditional marketing authorisation to a standard marketing authorisation. It was based on a Type 2 variation filed with the European Medicines Agency (EMA) in November 2023.
The full approval by EC follows a favourable opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in April 2024.
The latest approvals in both the US and the European Union (EU) were based on findings from the first large-scale, randomised, multi-country open-label, Phase 3 STREAM Stage 2 study.
STREAM Stage 2 studied the efficacy and safety of an all-oral bedaquiline-containing regimen for the treatment of MDR-TB.
The results have confirmed that treatment regimens containing bedaquiline significantly improved treatment outcomes compared to regimens that included injectable medications.
In a separate development, Johnson & Johnson reported positive results from a prespecified second interim analysis of the Phase 3 CARTITUDE-4 study evaluating Carvykti (ciltacabtagene autoleucel) for multiple myeloma.
Carvykti achieved statistically significant and clinically meaningful improvement in overall survival (OS) compared to standard therapies for the treatment of patients with relapsed or lenalidomide-refractory multiple myeloma after one prior line of therapy.
