Approval for CSL's AFSTYLA

Company News

CSL Behring has welcomed TGA approval of its AFSTYLA, the first and only single-chain recombinant factor VIII specifically designed to treat haemophilia A, which will reduce the number of injections required by patients.

According to the company, for an estimated 81 per cent of severe haemophilia A patients who receive injections every second day or three times a week, the switch to AFSTYLA will reduce the number of injections required for prophylaxis therapy without compromising control of bleeding.

Dr Andrew Cuthbertson, Chief Scientific Officer and Director R&D, CSL Limited said, “TGA approval of AFSTYLA - an innovative and effective haemophilia 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. We are very excited to add this treatment to our industry-leading portfolio of coagulation therapies.”

Haemophilia treatments are funded through tender arrangements administered by the National Blood Authority.

CSL Behring said it is “committed to bringing AFSTYLA to Australian patients and intends to work with the health care community to provide effective treatment options for people with haemophilia A.”

“The Australian Haemophilia Centre Director’s Organisation (AHCDO) views the development of new effective clotting factor concentrates as a further step forward in the management of our patients with haemophilia,” said Dr Simon McRae, Consultant Haematologist and Chairman of AHCDO. “The ability to prevent the vast majority of bleeding events with less frequent infusions has the potential to improve long-term outcomes in individuals with haemophilia.”

Approval of AFSTYLA has been based on results from the AFFINITY clinical trial program. AFFINITY includes Phase I through to Phase III open-label, multicentre studies evaluating the safety and efficacy of AFSTYLA in children and adults (ages 1 to 61 years) with severe haemophilia A.

Gavin Finkelstein, President of the Haemophilia Foundation Australia said, “The community is very pleased to see the approval of new treatment opportunities for people with haemophilia A.”

Haemophilia A is a congenital bleeding disorder characterised by deficient or defective factor VIII - nearly all affected patients are male. People with Haemophilia A may experience prolonged or spontaneous bleeding, especially into the muscles and joints. In Australia, there are 2158 people with Haemophilia A (640 with severe Haemophilia A) according to the Australian Bleeding Disorders Registry.