Posted by Michael Wonder on 12 Aug 2019
Janssen announces U.S. FDA accelerated approval for Sirturo (bedaquiline) as part of combination therapy to treat adolescents with pulmonary multidrug-resistant tuberculosis
9 August 2019 - Label expansion marks important milestone in Johnson & Johnson’s paediatric research and development program for bedaquiline.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. FDA has granted approval for Sirturo (bedaquiline) tablets as part of combination therapy in paediatric patients – those over the age of 12 and younger than 18 and weighing at least 66 pounds (30 kilograms) – with pulmonary multidrug-resistant tuberculosis (MDR-TB), when an effective treatment regimen cannot otherwise be provided.
Today’s U.S. FDA approval is supported by evidence from a single-arm, open-label, Phase 2 study that enrolled 15 paediatric patients with confirmed or probable MDR-TB infection.
