CSL Behring , world leader in biotherapeutics, announced today that the European Medicines Agency (EMA) has approved the new summary of product characteristics, which includes information on new extended dosing options for IDELVION ® [albutrepenonacog alfa, coagulation factor IX (recombinant), albumin fusion protein (rFIX-FP)], the innovative long-acting recombinant albumin fusion protein from CSL Behring for the treatment of hemophilia B 1. The regimen for routine prophylaxis has been updated to include new data on the possibility of further prolongation of the treatment interval up to 21 days for appropriate adult patients. This makes IDELVION ® the first and only factor IX therapy that can be used with a 21-day dosing regimen, according to the information in the summary of product characteristics 2 .

"This longer treatment interval provides the opportunity for additional dosing options for patients and healthcare professionals, further enhancing personalized treatment with IDELVION ®,  " said Dr. Giancarlo Castaman , Director of the Treatment Center of hemophilia and other hemorrhagic diseases at Careggi Hospital, Florence, Italy.

"We listened to our patients and shared their vision for the promise of a treatment offering personalized therapy with a dosage regimen extended beyond 14 days," added Dr. Lutz Bonacker , senior vice president and general manager for the ' Europe at CSL Behring. “We are proud to be the only company to offer a product like IDELVION ® with many flexible dosing options with the potential to reduce the burden of treatment for many patients. "

IDELVION ® , the most widely prescribed prophylactic treatment for hemophilia B worldwide 3 , is the first and only factor IX therapy with the option of a 21-day dosage.

About hemophilia B

Hemophilia B is a congenital hemorrhagic disorder characterized by a defective or deficient coagulation factor IX. Almost all of the affected patients are men. People with hemophilia B can experience prolonged or spontaneous bleeding, especially in the muscles, joints, or internal organs. According to the United States Centers for Disease Control and Prevention, this disease affects approximately one in every 25,000 male children.

About IDELVION ®

IDELVION ® , albutrepenonacog alfa, is indicated in children and adults with hemophilia B (congenital factor IX deficiency) for the treatment and prophylaxis of bleeding.

The approved 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. The information currently available on IDELVION ® supports extending treatment intervals for some patients up to 21 days, although this is potentially associated with an increased risk of bleeding compared to a once-weekly regimen.

IDELVION is contraindicated in patients with potentially fatal hypersensitivity to the product or its components, including hamster proteins.

CSL Behring designed IDELVION ® to extend the half-life of recombinant factor IX through fusion with recombinant albumin. CSL Behring chose recombinant albumin as a fusion partner for its clotting factor proteins because of its long physiological half-life. In addition, recombinant albumin has been shown to have a good tolerance profile, low potential for immunogenic reactions, and a known folding mechanism.

IDELVION® is also approved in the United States and Canada .

The European Commission has approved IDELVION ® as an orphan drug intended for the safe, effective treatment, prevention or diagnosis of rare life-threatening or chronically debilitating diseases which affect not more than 5 in 10,000 people across the Europe .

To learn more about CSL Behring's recombinant products being developed to treat hemophilia, go to: http://www.cslbehring.com/products/bleeding-disorders/novel-recombinant-hemophilia -treatments

About CSL Behring

CSL Behring  is a world leader in biotherapeutics motivated by its promise to save lives. Focusing on meeting the needs of patients using the latest technology, we develop and provide innovative therapies that are used to treat bleeding disorders, primary immune deficits, hereditary angioedema, respiratory diseases and neurological disorders. The company's products are also used in heart surgery, for the treatment of burns and to prevent hemolytic disease in newborns.

CSL Behring operates one of the largest plasma collection networks in the world, CSL Plasma. The parent company, CSL Limited  (ASX: CSL; USOTC: CSLLY), headquartered in Melbourne , Australia, employs more than 25,000 people and provides life-saving treatment 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 .

References

1. European Medicines Agency, IDELVION Product Information, https://www.ema.europa.eu/en/medicines/human/EPAR/idelvion#product-information-section
2. European Medicines Agency, Summary of product characteristics IDELVION, https://www.ema.europa.eu/en/documents/product-information/idelvion-epar-product-information_en.pdf
3. Adivo Q42019 quarterly report, internal data

Media Contact
Jennifer Purdue
Mobile: +1 610 306 9355
E-mail: jennifer.purdue@cslbehring.com

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