STREAM Stage 2 study data submitted as part of Type II Variation to European Medicines Agency and supplemental New Drug Application to U.S. FDA aim to support the full and traditional approval in the European Union and U.S., respectively.

TITUSVILLE, NJ, August 9, 2019 — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has granted approval for SIRTURO^® (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.

Janssen's response to TB CAB letter regarding pharmacokinetic studies, paediatric studies, and compassionate use of bedaquiline.