J&J receives positive CHMP opinion recommending approval of Sirturo in MDR TB

Johnson & Johnson announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended the approval of a Type II variation for SIRTURO and the conversion of the medicine’s Conditional Marketing Authorisation into a standard Marketing Authorization. SIRTURO is currently indicated for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis in adult and pediatric patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. The positive CHMP recommendation is supported by data from the Phase 3 STREAM Stage 2 study, the first large-scale, randomized, multi-country clinical study to evaluate the efficacy and safety of an all-oral bedaquiline-containing regimen for treatment of MDR-TB. Results from the study showed bedaquiline-containing regimens offered a significant improvement over other therapies, confirm the positive risk-benefit of treatment with bedaquiline and were published in The Lancet in November 2022. SIRTURO was first granted accelerated approval by the U.S. Food and Drug Administration in December 2012 and conditional approval by the EMA in March 2014 following positive Phase 2 study data. In addition to the Type II variation filed with EMA, a supplemental New Drug Application was submitted to the FDA in August 2023 to support the transition to full approval in the U.S., and is currently under review.