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CSL Behring receives approval from the European Commission for IDELVION to treat bleeding in patients with hemophilia B.

M2 EQUITYBITES-May 11, 2016-CSL Behring receives approval from the European Commission for IDELVION to treat bleeding in patients with hemophilia B

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Biotherapeutics company CSL Behring declared on Wednesday that its IDELVION (albutrepenonacog alfa) has been approved by the European Commission.

IDELVION is a long-acting albumin fusion protein that links recombinant coagulation factor IX with recombinant albumin for the treatment and prophylaxis of bleeding in patients with hemophilia B, a congenital factor IX deficiency. IDELVION can be used to treat both children and adults with an approved treatment regimen that includes routine prophylaxis to prevent or reduce the frequency of bleeding episodes; on-demand control; and the perioperative management of bleeding around the time of surgery.

According to CSL Behring, IDELVION delivers high-level protection maintaining factor IX activity levels above 5% in the majority of patients over 14-days.

The company added that IDELVION is also approved in the US and Canada. It will be launched in European markets in the coming months, as market access and pricing are obtained.

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Publication:M2 EquityBites (EQB)
Date:May 11, 2016
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