Johnson & Johnson’s Sirturo Gains the CHMP’s Positive Opinion to Treat Multidrug-Resistant Tuberculosis
Shots:
- 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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
