The CHMP has granted positive opinion to the company’s Sirturo (bedaquiline) and recommended approving its Type II variation plus transitioning its conditional marketing authorization into a standard marketing authorization
The opinion was based on the data from P-III (STREAM) stage 2 trial assessing the safety & efficacy of bedaquiline-containing regimen to treat MDR-TB, depicting improvement and confirming its positive risk-benefit
Additionally, Sirturo received the US FDA’s accelerated approval in Dec 2012 & the EMA’s conditional approval in Mar 2014 based on the P-II study results. Its sNDA, submitted to the US FDA in Aug 2023, is underway for full approval
Ref: Johnson & Johnson | Image: Johnson & Johnson
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