CSL haemophilia drug wins Europe approval
Vaccines and blood products supplier CSL has secured marketing authorisation from the European Commission for its new treatment for haemophilia A and expects to launch the product in Europe in the coming months.
Haemophilia A is a congenital bleeding disorder characterised by a deficient or defective blood-clotting protein known as factor VIII.
People with haemophilia A can experience prolonged or spontaneous bleeding into the muscles, joints or internal organs.
CSL’s new treatment, called AFSTYLA, was designed for greater molecular stability and longer duration of action, and can be used for all ages.
“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,” CSL chief scientific officer and research and development director Andrew Cuthbertson said on Monday.
“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.”
CSL said AFSTYLA will be launched in European markets in the coming months as market access is obtained.
About one in 10,000 people are born with haemophilia, and most have haemophilia A.
Shares in CSL were 97 cents higher at $103.30 at 1037 AEDT.