CSL Behring, a global biotherapeutics company focused on the development and delivery of innovative therapies that are used to treat coagulation disorders, announced this week that the European Commission has approved Idelvion (albutrepenonacog alfa), its long-acting albumin fusion protein for the treatment of bleeding in patients with hemophilia B (congenital factor IX deficiency).
The announcement comes on the heels of approval from the U.S. FDA in March.
The approval of Idelvion by both the FDA and European Commission is based on results from the PROLONG-9FP clinical development program. PROLONG-9F, which included Phase 1 through Phase 3 open-label, multicenter studies that evaluated the safety and efficacy of the drug in patients ages 1 to 61 years old with hemophilia B (factor IX levels less than or equal to 2 percent).
The trial results showed that Idelvion delivers high-level protection maintaining factor IX activity levels above 5 percent in most patients over 14 days. This means that for patients age 12 and older, excellent bleeding control can be achieved with up to a 14-day gap between infusions, ultimately reducing the amount of units necessary for successful prophylaxis therapy.
“Offering 14-day dosing, Idelvion helps patients maintain higher factor IX levels over a long period of time, providing them with greater freedom from frequent infusions. This is an important attribute for my patients who require a prophylactic regimen but don’t want treatment to disrupt their active lives,” said Dr. Elena Santagostino, MD, PhD, professor at the Medical School of Clinical and Experimental Hematology at the University of Milan/IRCCS Maggiore Hospital, and lead investigator of the PROLONG-9FP clinical development program, in a press release.
“Idelvion provides excellent bleeding control by maintaining factor IX activity levels above 5 percent over a prolonged period of time,” said Dr. Andrew Cuthbertson, chief scientific officer and R&D director at CSL Limited. “Idelvion delivers on CSL’s 100 year promise to develop and provide innovative specialty biotherapies that patients need and want. We look forward to bringing Idelvion to the European market and are particularly excited about the positive impact this long-acting therapy can have on the lives of patients with hemophilia B as we enter our next century.”