Johnson & Johnson’s Sirturo Gains the US FDA & EC’s Approval to Treat Pulmonary Tuberculosis
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- The US FDA has granted full approval to Sirturo (bedaquiline) as a combination therapy for treating adults & pediatric patients (≥5yrs., weight: at least 15kg) with pulmonary TB, resistant to rifampicin & isoniazid. It received accelerated approval in Dec 2012
- Following the CHMP’s positive opinion in Apr 2024, the EC has also transformed its conditional approval, received in Mar 2014 based on P-II study data, to full approval for same indication
- Approvals were based on P-III (STREAM) Stage 2 trial assessing the safety & efficacy of oral bedaquiline-containing regimen to treat MDR-TB. Data, published in The Lancet in Nov 2022, showed improved treatment results with vs injectable-containing regimens
Ref: Johnson & Johnson | Image: Johnson & Johnson
Related News:- Johnson & Johnson’s Sirturo Gains the CHMP’s Positive Opinion to Treat Multidrug-Resistant Tuberculosis
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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.
