CSL Behring announced that new data from studies of two approved treatments for hemophilia — Idelvion and Afstyla, both recombinant coagulation factors — will be presented at the XXXII International Congress of the World Federation of Hemophilia (WFH) 2016 next week.
CSL will present six posters highlighting Idelvion, a long-acting recombinant albumin fusion protein, including interim results on a Phase 3b safety and efficacy study. Idelvion is an approved treatment for adults and children with hemophilia B in the U.S., the European Union and Canada.
Regulatory approvals were based on data from the PROLONG-9FP clinical development program, showing that Idelvion delivers high-level protection with up to 14-day dosing in appropriate patients, with a median annualized spontaneous bleeding rate (AsBR) of 0.00 for all treatment intervals. Data was published in Blood, in a study titled “Long acting recombinant coagulation factor IX albumin fusion protein (rIX-FP) in hemophilia B: results of a phase 3 trial.”
An additional oral presentation and six posters will showcase Afstyla, a long-acting recombinant factor VIII single-chain therapy for hemophilia A, and will highlight pediatric results from a Phase 3 pharmacokinetic, efficacy, and safety study.
Afstyla has been approved for the treatment of children and adults in the U.S., and is under consideration by regulatory agencies in Europe, Switzerland, and Australia. U.S. Food and Drug Administration (FDA) approval was based on data from the AFFINITY clinical development program, and data from this program was published in the scientific journal Blood, under the title “Efficacy and safety of rVIII-SingleChain: results of a phase I/III multicenter clinical trial in severe hemophilia A.”
“We are excited to share new clinical findings for Idelvion and Afstyla during WFH,” Dr. Andrew Cuthbertson, chief scientific officer and director of Research & Development at CSL, said in a press release. “These novel recombinant therapies and new data reinforce our promise to develop and deliver innovative specialty biotherapies that have the potential to improve patients’ lives.”
The WHF Congress will take place July 24–28 in Orlando, Florida. Details on the sessions and poster presentations can be found in the company’s release.
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