Blood products and vaccines developer CSL has received US regulatory approval for its new long-acting haemophilia treatment.
CSL says the factor IX treatment, called IDELVION, provides protection to patients for up to 14 days, which significantly reduces the number of infusions needed each month to prevent bleeds.
Deficiency of the factor IX protein causes haemophilia B and patients with severe haemophilia need intravenous infusions of factor IX to treat or prevent bleeding episodes.
People with haemophilia B - which affects about one in 25,000 male births - may experience prolonged or spontaneous bleeding into muscles, joints, or internal organs.
CSL on Monday said the US Food and Drug Administration (FDA) had approved IDELVION for use in the United States in children and adults with haemophilia B.
"We are proud to add this new therapy to our growing portfolio of bleeding disorder products, and are particularly excited about the positive impact treatment with IDELVION can have on the well-being of patients with haemophilia B," CSL's chief scientific officer, Dr Andrew Cuthbertson, said in a statement.
"IDELVION is the first product from our innovative recombinant factor development program to receive FDA approval."
IDELVION is already approved for use in Canada.
The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended granting marketing authorisation for IDELVION in the European Union.
Australia, Switzerland and Japan's regulators are reviewing CSL's licence applications for the treatment.
Shares in CSL were 15 cents higher at $103.15.
Share
