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
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
