Janssen: FDA Accelerated Approval for SIRTURO to Treat Resistant TB in Teens

Label Expansion Marks Important Milestone in Johnson & Johnson’s Pediatric Research And Development Program For Bedaquiline

* * *

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has granted approval for SIRTURO(R) (bedaquiline) tablets as part of combination therapy in pediatric 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. Approved under the FDA’s accelerated approval pathway based on time to sputum culture conversion, bedaquiline can now be used as part of combination therapy for eligible MDR-TB patients aged 12 years and over in the U.S. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.

The FDA approval marks the first regulatory milestone as part of the company’s global pediatric research and development (R&D) program for bedaquiline, with additional global regulatory filings planned. Further research is ongoing in children younger than 12 years of age using a pediatric formulation of bedaquiline.

https://www.marketscreener.com/JOHNSON-JOHNSON-4832/news/Johnson-Johnson-Janssen-Announces-FDA-Accelerated-Approval-for-SIRTURO-As-Therapy-to-Treat-Adole-29050242/