Posted by Michael Wonder on 30 Apr 2024
Johnson & Johnson receives positive CHMP opinion recommending full approval for Sirturo (bedaquiline) for treatment of multidrug-resistant tuberculosis
29 April 2024 - Recommendation supported by results from the Phase 3 STREAM Stage 2 study, which show bedaquiline-containing regimens offer significant improvement compared to other available therapies.
Johnson & Johnson announced today that the CHMP of the EMA has recommended the approval of a Type II variation for Sirturo (bedaquiline) and the conversion of the medicine’s conditional marketing authorisation into a standard marketing authorisation.
