Source: CSL Behring & reported by http://www.prnewswire.com/
ORLANDO, Fla., July 26, 2016 /PRNewswire/ -- CSL Behring today announced new data from its Phase III PROLONG-9FP clinical development program evaluating IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein], the company's novel, long-acting recombinant albumin fusion protein for treating hemophilia B. The data, from a Phase III study and an ongoing extension study, assessed the long-term efficacy and safety of IDELVION for routine prophylaxis in previously treated children and adults with hemophilia B. The results showed that extended prophylaxis treatment regimens effectively prevented bleeds while also reducing overall IDELVION consumption. The findings were presented at the XXXII International Congress of the World Federation of Hemophilia (WFH) in Orlando, Fla., July 24 – 28, 2016. Separately, an abstract reporting efficacy and safety results of IDELVION in hemophilia B patients undergoing surgery was also presented.
"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, M.D., Ph.D., Professor in 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. "Interim results from the extension study are promising and suggest that extended treatment intervals of up to 10 and 14 days are achievable in children less than 12 years of age with hemophilia B, and even more prolonged treatment intervals of up to 21 days are conceivable for older patients."
Read more: http://www.prnewswire.com/news-releases/csl-behring-presents-phase-iii-data-for-idelvion-for-hemophilia-b-at-the-world-federation-of-hemophilia-2016-world-congress-300303994.html