AFSTYLAŽ, for Haemophilia A, Receives Positive Opinion from European Medicines Agency CHMP

Monday, November 14, 2016 Drug News
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-- CHMP positive opinion moves AFSTYLA one step closer to approval in the European Union

MARBURG, Germany, Nov. 14, 2016 /PRNewswire/ -- Global biotherapeutics leader CSL Behring announced today that the European Medicines Agency (EMA)

Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AFSTYLAŽ [Recombinant Human Coagulation Factor VIII, Single Chain] for patients with haemophilia A. AFSTYLA, CSL Behring's novel, recombinant factor VIII therapy for adults and children, 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.

"For 100 years, CSL has focused on researching and developing innovative therapies that meet the treatment challenges patients face," said Dr. Andrew Cuthbertson, Chief Scientific Officer and R&D Director, CSL Limited. "CHMP's positive opinion for AFSTYLAŽ moves us one step closer to bringing this novel treatment option to haemophilia A patients in the European Union. Once approved, AFSTYLA will provide adults and children with a therapy that delivers on our promise to develop and bring to market innovative specialty biotherapies that help patients live full lives." 

About Haemophilia APrimarily 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.

About AFSTYLAŽAFSTYLA (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. 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 U.S. In addition to the European Union, 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 16,000 people with operations in more than 30 countries. For more information visit and follow us on

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