Novo Nordisk receives EU approval for haemophilia B therapy Refixia

Novo Nordisk has announced that its drug Refixia has been approved in Europe as a treatment for haemophilia B.

The European Commission has approved the drug for the prevention and on-demand treatment of bleeding and surgical procedures in adolescent and adult patients with haemophilia B.

This approval was based on positive efficacy and safety findings generated from 115 patients across five pivotal clinical trials, with the authorisation following a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency earlier this year.

Novo Nordisk expects the commercial rollout of Refixia to commence in the first European countries during the fourth quarter of the year. 

Mads Krogsgaard Thomsen, executive vice-president and chief science officer of Novo Nordisk, said: "The strong clinical profile of Refixia provides haemophilia B patients with better protection against bleeds, even into damaged joints, and an overall improved quality of life."

This comes after the drug was approved by the US Food and Drug Administration at the end of last month.

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