Roche: EU extends authorisation for haemophilia A drug
(CercleFinance.com) - Roche has announced that the European Commission has approved the extension of the marketing authorisation (MA) for its Hemlibra (emicizumab) in the European Union to include people with moderate haemophilia A.
The label will now include routine prophylaxis of bleeding episodes in people with haemophilia A without factor VIII inhibitors, who have moderate disease with a severe bleeding phenotype.
This approval is based on the results of the HAVEN 6 study, where Hemlibra demonstrated effective bleeding control and a favourable safety profile in people with moderate haemophilia A without inhibitors.
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