Baxter files for EU approval of Rixubis for haemophilia B

Baxter has submitted a marketing authorisation application to the European Medicines Agency  for approval of Rixubis in the treatment of haemophilia B.

The company is seeking approval for the drug in the treatment and prophylaxis of bleeding in haemophilia B patients of all ages based on positive data from clinical trials, which have shown that Rixubis can deliver significant benefits in terms of preventing bleeding events.

Rixubis has already been approved in the US, with this new European regulatory filing coming as part of efforts by Baxter to make the therapy more widely available worldwide.

Dr Anders Ullman, vice-president of global research and development for Baxter's BioScience business, said: "Our focus at Baxter is to strengthen and expand the portfolio of treatments for patients with bleeding disorders, particularly when there are limited treatment options, such as for patients with haemophilia B."

This comes after the company announced the European launch of Hemopatch – a novel collagen-based haemostatic device – earlier this month.