IDELVION Prevents Bleeds and Reduces Drug Consumption in Hemophilia B Patients

Results from the Phase III PROLONG9FP ongoing extension clinical development program evaluating the long-term efficacy and safety of IDELVION (coagulation factor IX [recombinant], albumin fusion protein) showed that extended prophylaxis treatment regimens effectively prevented bleeds while also reducing overall IDELVION consumption. “These new data corroborate findings from the pivotal Phase III trials from PROLONG-9FP and demonstrate that IDELVION prophylaxis maintains robust efficacy and safety over time in pediatric and adult patients living with hemophilia B,” said Elena Santagostino, MD, PhD, professor in the medical school of clinical and experimental hematology at the University of Milan/ IRCCS Maggiore Hospital and lead investigator of the program. “Interim results from the extension study are promising and suggest that extended treatment intervals of up to 10 days and 14 days are achievable in children younger than 12 years old with hemophilia B, and even more prolonged treatment intervals of up to 21 days are conceivable for older patients.”

IDELVION, manufactured by CSL Behring, was approved by the U.S. Food and Drug Administration in March, in the European Union in May and in Canada in January 2016. In the U.S., IDELVION is indicated for children and adults with hemophilia B for routine prophylaxis to prevent or reduce the frequency of bleeding episodes, on-demand control and prevention of bleeding episodes, and the perioperative management of bleeding (around the time of surgery).