Johnson & Johnson announced yesterday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of a type II variant for Sirturo (bedaquiline) and conversion of the drug's conditional marketing authorization to a standard marketing authorization.

Sirturo is currently indicated as part of an appropriate combination therapy for multidrug-resistant pulmonary tuberculosis (MDR-TB) in adult and pediatric patients (aged 5 years to under 18 years and weighing at least 15 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

The CHMP's positive recommendation is based on data from a Phase 3 study.

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