European Medicines Agency Approves 21-Day Dosing Intervals for Adult Haemophilia B Patients
HATTERSHEIM, Germany, July 3, 2020 /PRNewswire/ -- Global biotherapeutics leader CSL Behring announced today that the European Medicines Agency (EMA) has approved the new Summary of Product Characteristics, which includes information about new, extended dosing options for IDELVION® [albutrepenonacog alfa, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rFIX-FP)], CSL Behring's novel, long-acting recombinant albumin fusion protein for treating haemophilia B1. The routine prophylaxis dosing regimen has been updated to include new data about the possibility of further extension of the treatment interval up to 21-day dosing for appropriate adult patients. This makes IDELVION® the first and only factor IX therapy that may be used with a 21-day dosing regimen, in accordance with the information contained within the SmPC2.
"This longer treatment interval provides the opportunity for additional dosing options for patients and healthcare professionals, thus improving further tailored treatment with IDELVION®," said Dr Giancarlo Castaman, Director of the Centre for Bleeding Disorders and Coagulation in Careggi Hospital, Florence, Italy.
"We listened to our patients and shared their vision for the promise of a therapy that provides a personalised therapy with an extended treatment regimen beyond 14 days," adds Dr.Lutz Bonacker, Senior Vice President and General Manager, Europe, CSL Behring. "We are proud to be the only company to offer a product like IDELVION® with broad flexible dosing options with the potential to reduce the treatment burden for many patients."
IDELVION®, the most prescribed prophylactic treatment for Haemophilia B globally3, is the first and only factor IX therapy with the possibility of 21-day dosing.
About Hemophilia B
Haemophilia B is a congenital bleeding disorder characterised by deficient or defective clotting factor IX; nearly all affected patients are male. People with haemophilia B may experience prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. According to the U.S. Centers for Disease Control and Prevention, the condition occurs in approximately one in 25,000 male births.
IDELVION®, albutrepenonacog alfa, is indicated in children and adults with haemophilia B (congenital factor IX deficiency) for the treatment and prophylaxis of bleeding.
The approved treatment regimen includes on-demand control and prevention of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Currently available information on IDELVION® support extension of treatment intervals for some patients up to 21 day, though potentially associated with an increased risk for bleeding compared to a once weekly regimen.
IDELVION is contraindicated in patients who have had life-threatening hypersensitivity to the product or its components, including hamster proteins.
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. Additionally, recombinant albumin has been shown to have a good tolerability profile, low potential for immunogenic reactions and a well-known mechanism of clearance.
IDELVION® is also approved in the United States and Canada.
The European Commission approved IDELVION® as an orphan medicinal product -- intended for the safe and effective treatment, prevention or diagnosis of life-threatening or chronically debilitating rare disease that affect not more than 5 in 10,000 people throughout Europe.
For more information about CSL Behring's recombinant products in development to treat haemophilia, visit http://www.cslbehring.com/products/bleeding-disorders/novel-recombinant-hemophilia-treatments
About CSL Behring
CSL Behring is a global biotherapeutics leader 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, respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, 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; USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 25,000 people, and delivers its life-saving therapies to people in more than 70 countries. For inspiring stories about the promise of biotechnology, visit Vita CSLBehring.com/vita and follow us on Twitter.com/CSLBehring.
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