J&J: full approval for Sirturo in tuberculosis
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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