Navigation Links
European Medicines Agency Commences Review of CSL Behring's Regulatory Submission for rIX-FP for Hemophilia B Patients

KING OF PRUSSIA, Pa., March 30, 2015 /PRNewswire/ -- CSL Behring announced today that the European Medicines Agency (EMA) has started the Centralized Procedure for reviewing the company's Marketing Authorization Application (MAA) for its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP).  Upon European Commission approval, rIX-FP will provide hemophilia B patients in the European Union (EU), as well as the European Economic Area (EEA) countries, with a long-acting treatment option with dosing intervals up to 14 days.  

"The EMA beginning its Centralized Procedure for rIX-FP is a significant milestone for CSL Behring's recombinant factor IX clinical development program and moves us one step closer to bringing this innovative therapy to hemophilia B patients in the EU and EEA," said Dr. Andrew Cuthbertson, Chief Scientific Officer and R&D Director, CSL Limited.  "CSL Behring's rIX-FP for hemophilia B patients further illustrates the company's protein science capabilities and strong partnership with the hemophilia community."  

In February 2015, the U.S. Food and Drug Administration accepted for review CSL Behring's Biologics License Application for rIX-FP. Pivotal data for rIX-FP will be presented during the International Society on Thrombosis and Haemostasis (ISTH) Congress in Toronto in June 2015.

About rIX-FP
CSL Behring engineered rIX-FP to extend the half-life of recombinant factor IX through genetic fusion with recombinant albumin. CSL Behring selected recombinant albumin as its recombinant genetic fusion partner for its coagulation factor proteins due to its long physiological half-life. In addition, recombinant albumin has been shown to have a good tolerability profile, low potential for immunogenic reactions and a well-known mechanism of clearance. The cleavable linker connecting recombinant factor IX and recombinant albumin has been specifically designed to preserve the native function of the coagulation factor in the fusion protein, while benefiting from recombinant albumin's long physiological half-life.

About PROLONG-9FP Clinical Development Program
CSL Behring's MAA is based on data from the PROLONG-9FP clinical development program, covering patients from the age of 1 to 61 years. Studies in the program were conducted as open-label, multicenter, safety and efficacy studies of rIX-FP in previously treated patients with hemophilia B (FIX </= 2%).

The Phase II/III pivotal study (patients ages 12 to 61 years) was designed to compare the change in frequency of spontaneous bleeding events between on-demand treatment and a weekly prophylaxis regimen in patients previously receiving only on-demand treatment; and the number of patients developing inhibitors against factor IX as primary outcome measures. The study evaluated multiple prophylaxis regimens, including 7-day and 14-day intervals.   A sub-study evaluated the prevention and control of bleeding in patients with hemophilia B undergoing a surgical procedure.

The primary outcome measures of the Phase III children study (patients ages 1 to 11 years) are PK parameters of rIX-FP and the number of subjects developing inhibitors against factor IX. All patients received a weekly prophylaxis regimen.

Study design details for rIX-FP (CSL654) are available at

About CSL Behring's Recombinant Factor Development Program
rIX-FP for the treatment of hemophilia B is a part of CSL Behring's Recombinant Factor Development program. The AFFINITY clinical development program is studying CSL Behring's recombinant Factor VIII SingleChain (rVIII-SingleChain) to treat hemophilia A. CSL Behring also continues to advance its long-acting recombinant fusion protein linking recombinant coagulation factor VIIa with recombinant albumin (rVIIa-FP) to control bleeding episodes in hemophilia patients who have inhibitors.

About Hemophilia B
Hemophilia B (congenital factor IX deficiency) is characterized by deficient or defective factor IX and affects approximately 1 in 25,000 to 50,000 people. Hemophilia B is a congenital bleeding disorder characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. Nearly all hemophilia B patients are male.

About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide.

CSL Behring therapies are used around the world to treat coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies, hereditary angioedema and inherited respiratory disease, and neurological disorders in certain markets. 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. CSL Behring is a global biopharmaceutical company and a member of the CSL Group of companies. The parent company, CSL Limited (ASX:CSL), is headquartered in Melbourne, Australia. For more information, visit

Greg Healy
CSL Behring
Office: 610-878-4841
Mobile: 610-906-4564

Logo -

Copyright©2015 PR Newswire.
All rights reserved

Related medicine technology :

1. Oramed Selected to Present at the 81st European Atherosclerosis Society Congress in Lyon, France, June 2-5, 2013
2. Hospira Data on European Biosimilar Epoetin, Retacrit, Affirm Treatment Response, Tolerability in Management of Anemia Secondary to Chemotherapy
3. CTI Announces Data Presentations at the 18th Congress of the European Hematology Association
4. AbbVie Presents Preliminary Results from Phase I Study of Investigational Oncology Compound ABT-199/GDC-0199 in Patients with High-Risk Chronic Lymphocytic Leukemia (CLL) at European Hematology Association Annual Meeting
5. U.S. and European Rheumatologists Agree That a Therapys Induction of Remission is One of the Attributes That Most Influences Their Prescribing Decisions in Rheumatoid Arthritis
6. Surveyed U.S. and European Neurologists Identify Better Seizure-Free Efficacy as One of the Greatest Unmet Needs in Treating Partial-Onset Seizures in Refractory Epilepsy Patients
7. European Orthopedic Market 2017 Forecasts: Hip, Knee & Shoulder Analysis in New Research Report at
8. Sorrento Therapeutics and IGDRASOL to Present Late Stage Clinical Data Updates on their Oncology Nanomedicine Platform at the Joint Meeting of the European Foundation for Clinical Nanomedicine and European Technology Platform on Nanomedicine in Base
9. EAACI Publishes the First European Guidelines for food-Allergy Sufferers
10. US and European Computer Aided Detection (CAD) Industry
11. Mature US and European coronary artery bypass graft device markets will Shrink through 2021
Post Your Comments:
(Date:9/28/2017)... Hill-Rom Holdings, Inc. (NYSE: HRC), will host ... webcast on Friday, November 3, 2017, beginning at 7:00 ... approximately 8:30 a.m. (CDT) / 9:30 a.m. (EDT). ... performance and guidance for 2018, Hill-Rom executives will also ... performance, and long-range financial outlook through 2020. ...
(Date:9/25/2017)... , Sept. 25, 2017  EpiVax, Inc., a ... design, and immune-engineering today announced the launch of ... development of personalized therapeutic cancer vaccines. EpiVax has ... exclusive access to enabling technologies to the new ... will lead EpiVax Oncology as Chief Executive Officer. ...
(Date:9/19/2017)... , Sept. 19, 2017   ZirMed Inc ., a ... today announced that it has been ranked #1 by its ... Book™ Rankings 2017 User Survey. ZirMed was recognized as ... large hospitals and medical centers over 200 beds and holds ... healthcare technology user survey history. ...
Breaking Medicine Technology:
(Date:10/13/2017)... Shelton, CT (PRWEB) , ... October 13, 2017 , ... ... and long-term care services, staged a mock evacuation of the facility as part of ... Department, Shelton Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well ...
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and ... explains one of the most popular and least understood books in the Holy Scriptures, ... puzzling descriptions that have baffled scholars for centuries. Many have tossed it off as ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... services for healthcare compliance program management, will showcase a range of technology and ... for Assisted Living (NCAL) Convention and Expo to be held October 14–18, 2017 ...
(Date:10/12/2017)... ... ... The American College of Medical Informatics (ACMI) will present the 2017 Morris F. ... AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual Symposium is taking place ... the field of medical informatics, this prestigious award is presented to an individual whose ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at Children’s ... the 49th Congress of the International Society of Paediatric Oncology (SIOP) Oct. ... Center for Cancer and Blood Disorders at Children’s National, and Stephen P. Hunger, ...
Breaking Medicine News(10 mins):