Posted by Michael Wonder on 01 Jun 2020
U.S. FDA approves new paediatric formulation of Sirturo (bedaquiline) as part of combination therapy to treat children with pulmonary multidrug-resistant tuberculosis
27 May 2020 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. FDA has granted approval for a new pediatric formulation of Sirturo (bedaquiline).
Sirturo is now indicated for use as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multidrug-resistant tuberculosis. In the U.S., the medicine should be reserved for use when an effective treatment regimen cannot otherwise be provided.
This indication received accelerated approval based on time to sputum culture conversion.
