Submission of phase III study data on pulmonary tuberculosis to the EMA and FDA for Sirturo (bedaquiline) – Janssen Pharma
The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), announced 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 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 multi-drug 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.
The applications include data from the Phase III STREAM Stage 2 study (NCT02409290), which is a Post-Marketing Requirement in the U.S., a Specific Obligation in the EU and a Post-Marketing Commitment in several other countries. STREAM Stage 2 is the first large-scale, randomized, multi-country clinical study to evaluate the efficacy and safety of an all-oral bedaquiline-containing regimen for MDR-TB. The study compared an all-oral, nine-month bedaquiline-containing regimen to the control regimen of a nine-month injectable-based regimen for the treatment of MDR-TB. The results were published in The Lancet in November 2022.
Sirturo, a product of Janssen Pharmaceutica NV, part of the Janssen Pharmaceutical Companies of Johnson & Johnson, was first granted accelerated approval by the FDA in December 2012 and conditional approval by the EMA in March 2014 following positive Phase II study data.If approved, these new applications will support the traditional approval in the U.S. and full approval in the European Union.