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News From the Food and Drug Administration
April 19, 2016

A First in Hemophilia B Therapy

JAMA. 2016;315(15):1555. doi:10.1001/jama.2016.3603

The FDA has approved a first-of-its-kind, long-acting hemophilia B therapy that fuses factor IX with the blood plasma protein albumin (http://1.usa.gov/1SoN3w8).

The therapy, marketed as Idelvion, is produced using recombinant DNA technology. It’s the first coagulation factor–albumin fusion protein product approved in the United States. By fusing factor IX with albumin, which has a very long circulatory half-life, drug manufacturer CSL Behring, of King of Prussia, Pennsylvania, created a treatment that in some patients can be used just once every 2 weeks. Other factor IX replacement therapies may be needed every few days.

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