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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.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
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.
Copyright (c) 2024 CercleFinance.com. All rights reserved.