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

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

KING OF PRUSSIA, Pa — 30/03/2015

rIX-FP Regulatory Submissions Now Made in EU and U.S.; Underscores CSL Behring's Legacy of Improving the Care for Patients with Bleeding Disorders

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.


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


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