AFSTYLA®, for Haemophilia A, Receives European Commission Approval
MARBURG, Germany — 09 January 2017
- CSL Behring’s AFSTYLA is the first and only single-chain therapy for haemophilia A
- The therapy has been specifically designed for greater molecular stability and duration of action through strong affinity to von Willebrand factor (VWF)
- AFSTYLA has been shown to offer excellent haemostatic efficacy in both prophylaxis and on-demand treatment, and the option of twice weekly dosing with low unit consumption
- European Commission approval of AFSTYLA delivers on CSL Behring’s promise to develop and provide patients in the European Union with specialty biotherapies that help them lead full lives
Global biotherapeutics leader CSL Behring announced today that the European Commission has granted marketing authorisation for AFSTYLA® [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. In clinical trials, AFSTYLA demonstrated a strong safety profile with no inhibitors observed in previously treated patients undergoing prophylaxis.
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.
“European Commission approval of AFSTYLA, an innovative and effective haemophilia A therapy, delivers on CSL Behring’s promise to develop and provide novel products that have the potential to improve patients’ lives,” said Dr. Andrew Cuthbertson, Chief Scientific Officer and R&D Director, CSL Limited. “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 haemophilia A patients in the European Union.”
AFSTYLA will be launched in European markets in the coming months, as market access is obtained.
Primarily affecting males, haemophilia A is a congenital bleeding disorder characterised by deficient or defective factor VIII. People with haemophilia A may experience prolonged or spontaneous bleeding, especially into the muscles, joints or internal organs. According to the World Federation of Hemophilia, about 1 in 10,000 people are born with haemophilia, the majority of whom have haemophilia A.
AFSTYLA (also known as rVIII-Single Chain) for haemophilia A is CSL Behring’s recombinant single-chain factor VIII specifically designed for greater molecular stability and longer duration of action through strong affinity to von Willebrand factor (VWF). AFSTYLA uses a covalent bond that forms one structural entity, a single polypeptide-chain, to improve the stability of factor VIII and provide factor VIII activity with the option of twice weekly dosing.
AFSTYLA is approved in the European Union, U.S. and Canada. Additionally, regulatory agencies in markets around the world, including Switzerland and Australia, are currently reviewing CSL Behring’s marketing applications for AFSTYLA. Regulatory submissions for AFSTYLA are based on results from the AFFINITY clinical development program. Data from AFFINITY were recently published in the American Society of Hematology’s publication Blood and data comparing the pharmacokinetics of AFSTYLA and octocog alfa in patients with severe haemophilia A were recently published in The World Federation of Hemophilia’s journal Haemophilia.
About CSL Behring
CSL Behring is a global biotherapeutics leader which is driven by its promise to serve patients’ needs by using the latest technologies. We develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL), headquartered in Melbourne, Australia, employs more than 17,000 people, providing its life-saving, life-changing therapies to people in more than 60 countries. For more information visit www.CSLBehring.com and follow us on www.Twitter.com/CSLBehring.