Afstyla (rFVIII) for haemophilia A, receives European Commission approval

CSL

9 January 2017 - CSL today announced that the European Commission has granted marketing authorisation for CSL Behring’s Afstylta [recombinant human coagulation factor VIII, single chain] for children and adults with haemophilia A. 

Afstyla, CSL Behring’s novel, recombinant factor VIII therapy, is the first and only single-chain product for haemophilia A. It is specifically designed for protection from bleeds with two or three times weekly dosing and low unit consumption at both dosing regimens.

Afstyla is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Afstyla can be used for all age groups.

Read CSL press release

Michael Wonder

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Michael Wonder

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Outcome , Europe , Blood product