Novo Nordisk (NVO) said Thursday that the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended marketing authorization for Frehemgo or denecimig in the European Union to treat haemophilia A, a bleeding disorder.
CHMP's positive opinion is based on the company's trial data that showed denecimig reduced annualised bleeding rate compared with prior clotting factor prophylaxis and on-demand treatment in patients, according to a statement.
The company said it expects to launch Frehemgo in European countries from Q4 onwards.
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