J&J: full approval for Sirturo in tuberculosis

(CercleFinance.com) - Johnson & Johnson announced that the FDA has granted full approval to Sirturo (bedaquiline) to treat resistant pulmonary tuberculosis in patients aged 5 years and older.


This approval removes the restrictions of the 2012 accelerated approval. The European Commission has also granted full approval.

The approvals are based on a Phase 3 study showing a significant improvement in treatment outcomes with a bedaquiline-containing regimen compared to regimens with injectables.

Sirturo is now a key component of WHO guidelines for drug-resistant tuberculosis.

Johnson & Johnson is committed to making this drug available in low- and middle-income countries, with over 845,000 courses shipped to 160 countries.

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