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FDA Approves Novo Nordisk's Esperoct To Treat Haemophilia A

Novo Nordisk announced that the US Food and Drug Administration has approved the Biologics License Application for Esperoct for the treatment of adults and children with
haemophilia A.

Esperoct is the brand name for turoctocog alfa pegol, N8-GP. ESPEROCT is indicated for use in adults and children with haemophilia A (congenital factor VIII deficiency) for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes and perioperative management of bleeding.

Novo Nordisk said it will not be able to launch ESPEROCT before 2020 in the USA, due to third-party IP agreements.

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