BERLIN — 10 July 2017
CSL Behring today presented data finding treatment with AFSTYLA® may result in low average product consumption without compromising efficacy in both the prophylaxis and on-demand settings. Results were presented at the International Society on Thrombosis and Haemostasis (ISTH) Congress 2017 in Berlin. AFSTYLA (also known as rVIII-SingleChain) is CSL Behring’s novel recombinant factor VIII single-chain therapy for haemophilia A and provides protection against bleeding with dosing just two to three times per week.
Using a previously-developed budget impact model, the study calculated and compared average consumption of product per patient (IU/kg) between AFSTYLA, dosed two to three times per week, and octocog alfa, dosed three to four times per week, among patients with haemophilia A. Dosing, median annualized bleeding rates and average number of infusions needed to treat bleeding were based on product prescribing information and other published data.
“Based on our findings, patients who are treated with AFSTYLA two or three times per week require less factor overall, compared with the standard acting product octocog alfa, to manage their condition, including treatment for bleeding events, and they experience long-lasting prophylactic and on-demand protection against bleeding,” said Songkai Yan, Director of Global Health Economics and Reimbursement Strategy, CSL Behring.
According to the results, the average monthly consumption of AFSTYLA among patients treated prophylactically (including treatment for bleeding events) was lower than octocog alfa by 6.4 percent among children, and by 16.7 percent among adolescents and adults. When excluding treatment of bleeding events, the average monthly consumption of AFSTYLA was lower than octocog alfa by 4.8 percent among children, and by 16.7 percent among adolescents and adults. In the on‐demand population, consumption of AFSTYLA per bleeding episode was lower than octocog alfa by 41.3 percent among children, and by 27.2 percent among adolescents and adults.
AFSTYLA is approved in the European Union, U.S., Canada, Australia and Switzerland. Regulatory submissions for AFSTYLA were based on results from the AFFINITY clinical development program. Data from AFFINITY were 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 published in The World Federation of Haemophilia’s rel="noopener noreferrer" journal Haemophilia.
About Haemophilia A
Primarily affecting males, haemophilia A is a congenital bleeding disorder characterized 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 Haemophilia, about 1 in 10,000 people are born with haemophilia, most of whom have haemophilia A.
AFSTYLA (rVIII-SingleChain) 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 to form 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. The single-chain Factor VIII molecule of AFSTYLA was originated by SK Chemicals Co. Ltd., a bio-pharmaceutical company in Korea, and licensed to CSL Behring in 2009.
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 rel="noopener noreferrer" networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL), headquartered in Melbourne, Australia, employs nearly 20,000 people, delivering its life-saving therapies to people in more than rel="noopener noreferrer" 60 countries. For more information visit www.CSLBehring.com and follow us on www.Twitter.com/CSLBehring.