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FDA Approves New Vial Size for Idelvion®

June 5, 2018

CSL Behring recently announced that the US Food and Drug Administration (FDA) has approved a new 3500 IU (international unit) vial size for the company’s recombinant factor IX (rFIX) product Idelvion®. Idelvion combines or “fuses” recombinant factor IX (rFIX) with albumin, a protein found in blood plasma that helps factor IX stay active in the bloodstream longer.

The therapy was first approved by the FDA in 2016 for on-demand control and prevention of bleeding episodes, management of bleeding following surgery (perioperative) and as a routine preventive prophylaxis measure to reduce the incidence of bleeding episodes in patients with hemophilia B, or FIX deficiency.

“Having a variety of vial sizes available for patients, particularly larger vials, increases convenience for patients in optimizing their administration regimen,” said Craig Kessler, MD, Director, Division of Coagulation and Director of the Hemophilia and Thrombosis Comprehensive Care Center, Georgetown University Medical Center. “The 3500 IU vial can be helpful for patients currently on IDELVION or those who might have been waiting until more convenient vial sizes were available in order to begin treatment with IDELVION.”

Source: CSL Behring press release dated May 31, 2018