
FDA approves CSL haemophilia A drug
pharmafile | May 26, 2016 | News story | Sales and Marketing | CSL, afstyla, haemophilia a, treatment
CSL (ASX: CSL) has announced that the US Food and Drug Administration (FDA) has approved Afstyla (antihaemophilic factor [recombinant), single chain) for the treatment of haemophilia A.
The drug is a long-lasting recombinant factor VIII single-chain therapy indicated for adults and children with haemophilia A for routine prophylaxis to prevent or reduce the frequency of bleeding episodes. It can also be used for on-demand treatment and control of bleeding episodes, as well as the perioperative management of bleeding.
It is expected to be made available in the US within the next few months.
Dr Andrew Cuthbertson, chief scientific officer at CSL, says: “The approval of Afstyla, an innovative and effective haemophilia A therapy, further demonstrates CSL’s dedication to developing and delivering novel therapies that have the potential to improve patients’ lives. We are very excited to add this treatment to our industry-leading portfolio of coagulation therapies and look forward to the positive impact Afstyla can have on patients with haemophilia A.”
Sean Murray
Related Content

Roche candidate shows early promise for treating haemophilia A
Roche has announced encouraging early results from its phase 1/2 trial of NXT007, an investigational …
First patients treated with HEMGENIX® (etranacogene dezaparvovec) gene therapy for haemophilia B in Denmark
21 January 2025 – Copenhagen, Denmark – CSL Behring Denmark today announced that the first …

EC grants marketing authorisation to Sobi’s Altuvoct for haemophilia A treatment
Sobi has announced that the European Commission (EC) has granted marketing authorisation for Altuvoct (efanesoctocog …






