Extended half-life (EHL) factor concentrates to treat hemophilia A and B are alternatives to regular prophylaxis (preventive treatment). This treatment approach is also used as a preventive measure, but EHL products work for longer periods of time after administration, requiring fewer injections – what researchers call extended half-life.
There are three main ways of producing EHL factor concentrates: by Fc fusion, by polyethylene glycol conjugation (or PEGylation), and by albumin fusion.
Albumin fusion is an approach that combines albufuse with yeast expression technology where the clotting factor concentrate is molecularly fused to albumin, a naturally occurring protein found in the blood. The technology offers a natural alternative to PEGylation. The increased half-life of albumin fusion factors means patients need less frequent administration and a lower dosage.
Albumin fusion factors have been shown to have fewer side effects and improved tolerance, and have competitive production costs. They are also free of animal products and are produced molecularly.
Fusion proteins have been studied broadly and have wide applications in biopharmaceutics. Albumin fusion proteins are easy to construct and purify and remain stable longer.
The first albumin fusion protein drug approved by the U.S. Food and Drug Administration (FDA) was Tanzeum (albiglutide) for the treatment of diabetes. Since then, Egranli (balugrastim) and other albumin fusion proteins have been developed and evaluated in clinical trials.
The most commonly used albumin fusion product for the treatment of hemophilia B is Idelvion (albutrepenonacog alfa) also known as CSL654. Developed by CSL Behring, Idelvion is a fusion protein where recombinant coagulation factor IX is linked to recombinant albumin. It is indicated for the treatment and prevention of bleeding episodes in people with hemophilia B. Idelvion has been approved by the FDA, the European Medicines Agency (EMA), and Swiss health authorities.
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