CHMP Backs Two Hemophilia B Drugs (Idelvion and Alprolix )

Megan Brooks

Disclosures

February 29, 2016

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for two blood coagulation factor IX products for treatment and prophylaxis of bleeding in patients with hemophilia B.

They are albutrepenonacog alfa (Idelvion, CSL Behring GmbH) and eftrenonacog alfa (Alprolix, Biogen Idec Ltd). Both can be used in all age groups, the committee said.

Idelvion was designated as an orphan medicinal product in 2010. It will be available as 250 IU, 500 IU, 1000 IU, and 2000 IU powder and solvent for solution for injection.

Alprolix was designated as an orphan medicinal product in 2007. It will be available as 250 IU, 500 IU, 1000 IU, 2000 IU, and 3000 IU powder and solvent for solution for injection.

Both products work as "replacement therapy and temporarily increases plasma levels of factor IX, helping to prevent and control bleeding," EMA said in a news release. Both products have the ability to "stop the bleeding when given on demand and prevent bleeding when used as routine prophylaxis or for surgical procedures."

The most common side effects with Idelvion are injection-site reaction and headache, and with Alprolix, headache, paresthesia oral, and obstructive uropathy.

The CHMP recommends that Idelvion and Alprolix be prescribed by physicians experienced in managing patients with hemophilia B.

Detailed recommendations for the use of Idelvion and Alprolix will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after marketing authorization has been granted by the European Commission.

The US Food and Drug Administration approved Alprolix for use in children and adults with hemophilia B in 2014.

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