(CercleFinance.com) – Johnson & Johnson announced yesterday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had recommended the approval of a type II variant for Sirturo (bedaquiline ) and the conversion of the conditional marketing authorization of the medicinal product into a standard marketing authorization.
Sirturo is currently indicated as part of appropriate combination therapy for multidrug-resistant pulmonary tuberculosis (MDR-TB) in adult and pediatric patients (aged 5 years to less than 18 years and weighing at least 15 kg) when a effective treatment the treatment regimen cannot be composed otherwise for reasons of resistance or tolerability.
The CHMP’s positive recommendation is based on data from a phase 3 study.
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