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CSL Behring Presents Phase III Data for IDELVION® for Hemophilia B at the Federation of Hemophilia 2016 World Congress

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Wednesday, July 27, 2016

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ORLANDO, Florida - 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 thatIDELVION 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."

In 2016, IDELVION was approved in the U.Sin March, the European Union in May and Canada in January.  In the U.S., IDELVION is indicated for use in 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). Regulatory approvals of IDELVIONwere based on results from the global PROLONG-9FP clinical development program, which included five Phase I through Phase III open-label, multicenter studies evaluating the pharmacokinetics, safety and efficacy ofIDELVION in children and adults with hemophilia B.

About Hemophilia B 
Hemophilia B is a congenital bleeding disorder characterized by deficient or defective factor IX; nearly all affected patients are male. People with hemophilia B may experience prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. According to the U.S. Centers for Disease Control and Prevention, the condition affects approximately one in 25,000 male births.  

About IDELVION® 
CSL Behring engineered IDELVION to extend the half-life of recombinant factor IX through fusion with recombinant albumin. CSL Behring selected recombinant albumin as its fusion partner for its coagulation factor proteins due to its long physiological half-life.

IDELVION is approved in the United States, European Union and Canada. Regulatory agencies in Australia,Switzerland and Japan are also currently reviewing CSL Behring's license applications for IDELVION. 

About CSL Behring 
CSL Behring is a global biotherapeutics leader which is driven by its promise to save lives. Focused on serving patients' needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL), headquartered in Melbourne, Australia, employs more than 16,000 people with operations in more than 30 countries. 

Contact
Greg Healy  
CSL Behring  
610-878-4841  
610-906-4564  
Greg.Healy@CSLBehring.com 

Source: CSL Behring
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2.8 from 4 votes
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