IDELVION® (rFIX-FP) - CHMP recommendation

IDELVION® (rFIX-FP) - CHMP recommendation

Melbourne, Australia — 29/02/2016

CSL Limited (ASX:CSL; USOTC:CSLLY) - CSL today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for IDELVION® (Coagulation Factor IX (Recombinant), Albumin Fusion Protein) for patients with haemophilia B. IDELVION® is CSL Behring’s long-acting fusion protein, linking recombinant coagulation factor IX with recombinant albumin. IDELVION® was designated as an orphan medicinal product in 2010 by the European Commission.


“CHMP’s positive opinion for IDELVION® moves us one step closer to bringing this long-acting treatment option to haemophilia B patients in Europe,” said Dr. Andrew Cuthbertson, Chief Scientific Officer and R&D Director, CSL Limited. “Once approved, IDELVION® will provide haemophilia B patients in the European Union with a treatment option with prolonged dosing intervals up to 14 days. These intervals have been achieved while maintaining high levels of factor activity and very low annualized bleeding rates, delivering on our promise to develop and bring to market innovative specialty biotherapies that help patients live full lives.”

About Haemophilia B

Haemophilia B is a congenital bleeding disorder characterized by deficient or defective factor IX. Haemophilia B affects more than 10,000 people throughout Europe according to the European Haemophilia Consortium.


CSL Behring engineered IDELVION® to extend the half-life of recombinant factor IX through fusion with recombinant albumin. CSL Behring selected recombinant albumin as its fusion partner for its coagulation factor proteins due to its long physiological half-life.

IDELVION® is approved in Canada and regulatory agencies in the U.S., Australia, Switzerland and Japan are also currently reviewing CSL Behring’s license applications for IDELVION®.

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For further information, please contact:

  Mark Dehring
  Head of Investor Relations
  CSL Limited
  Phone: +613 9389 3407
  Sharon McHale
  Senior Director Public Affairs
  CSL Limited
  Phone: +613 9389 3425
  Mobile: +614 0997 8314

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