Health Canada Approves CSL Behring's AFSTYLA™ for the Treatment of Hemophilia A

-AFSTYLA is the first and only single-chain recombinant factor VIII for hemophilia A, specifically designed for long-lasting protection from bleeds with twice-weekly dosing available

-In clinical trials, patients undergoing prophylaxis with AFSTYLA experienced a median annualized spontaneous bleeding rate (AsBR) of zero

-AFSTYLA demonstrated a strong safety profile with no inhibitors observed in previously treated patients undergoing prophylaxis

OTTAWA, Ontario, Dec. 14, 2016 /PRNewswire/ -- Global biotherapeutics leader CSL Behring announced that Health Canada has approved AFSTYLA [Antihemophilic Factor VIII (Recombinant), SingleChain], its novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A. AFSTYLA is the first and only single-chain product for hemophilia A that is specifically designed for long-lasting protection from bleeds with two to three times weekly dosing. In clinical trials, patients undergoing prophylaxis with AFSTYLA experienced a median annualized spontaneous bleeding rate (AsBR) of zero. Once activated, AFSTYLA is identical to natural factor VIII.  AFSTYLA also demonstrated a strong safety profile with no inhibitors observed in previously treated patients undergoing prophylaxis.

AFSTYLA is indicated in adults and children with hemophilia A for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; control and prevention of bleeding episodes; and perioperative management of bleeding (surgical prophylaxis).

"Health Canada approval of AFSTYLA, an innovative and effective hemophilia A therapy, further demonstrates CSL Behring's dedication and century long promise to develop and deliver novel treatments that have the potential to improve patients' lives," said Dr. Andrew Cuthbertson, Chief Scientific Officer and Director of R&D, 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 patients with hemophilia A."

About Hemophilia APrimarily affecting males, hemophilia A is a congenital bleeding disorder characterized by deficient or defective factor VIII. People with hemophilia A may experience prolonged or spontaneous bleeding, especially into the muscles, joints or internal organs. According to the Canadian Hemophilia Society, hemophilia A affects fewer than 1 in 10,000 people, or about 2,500 Canadians.

About AFSTYLAAFSTYLA (also known as rVIII-SingleChain) for hemophilia 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. and Canada. Regulatory agencies in markets around the world, including the European Union, Switzerland and Australia, are currently reviewing CSL Behring's marketing applications for AFSTYLA.

Health Canada approval of AFSTYLA is based on results from the AFFINITY clinical development program. AFFINITY includes two pivotal and one extension open-label multi-center studies evaluating the safety and efficacy of AFSTYLA in children, adolescents and adults with hemophilia A. 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.

Important Safety InformationAFSTYLA, Antihemophilic Factor VIII (Recombinant), SingleChain, is indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for:

• Control and prevention of bleeding episodes,
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes,
• Perioperative management of bleeding (surgical prophylaxis).

Safety and efficacy data are not available for previously untreated patients (PUPs).

AFSTYLA is not indicated for treatment of Von Willebrand disease.

AFSTYLA is contraindicated in patients who have had life-threatening hypersensitivity reactions to AFSTYLA or its excipients, or to hamster proteins.

AFSTYLA is for intravenous use only.  AFSTYLA can be self-administered or administered by a caregiver with training and approval from a healthcare provider or hemophilia treatment center. Higher dose per kilogram body weight and/or more frequent dosing may be needed for patients under 12 years of age.

Hypersensitivity reactions, including anaphylaxis, are possible.  Advise patients to immediately report symptoms of a hypersensitivity reaction. If symptoms occur, discontinue AFSTYLA and administer appropriate treatment.

Development of factor VIII (FVIII) neutralizing antibodies (inhibitors) can occur. If expected factor VIII activity levels are not attained or bleeding is not controlled with appropriate dose, perform an assay to measure factor VIII inhibitor concentration.

Monitor plasma factor VIII activity using a chromogenic assay or one-stage clotting assay. If one-stage clotting assay is used, multiply result by a conversion factor of 2 to determine factor VIII activity level.

The most common adverse reactions (>1%) reported in clinical trials were rash, pyrexia, dizziness, hypersensitivity, and paraesthesia.

About CSL Behring CSL Behring is a global biotherapeutics leader which is driven by its promise to save lives. Focused on serving 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 with operations in more than 30 countries. For more information visit www.cslbehring.com and follow us on www.Twitter.com/CSLBehring.

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SOURCE CSL Behring