Janssen submits Phase 3 study data to the European Medicines Agency and U.S. Food and Drug Administration for SIRTURO® (bedaquiline)
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.
New Brunswick, N.J., (November 7, 2023) – The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), announced today the submission of a Type II Variation application to the European Medicines Agency (EMA) for the Company’s medicine SIRTURO® (bedaquiline). A supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) was also submitted in August 2023. SIRTURO® is indicated in adults and pediatric patients (5 years to less than 18 years of age and weighing at least 15 kg) as part of combination therapy of pulmonary tuberculosis (TB) due to multidrug-resistant Mycobacterium tuberculosis. The approved indication may vary per country. These submissions reflect the Company’s longstanding commitment to patients affected by multidrug-resistant TB (MDR-TB), one of the world’s most significant global health challenges.
