FDA OKs Baxalta’s Pegylated Hemophilia Therapy

The biopharmaceutical company, Baxalta Incorporated, has received US Food and Drug Administration (FDA) approval for Adynovate (antihemophilic factor (recombinant), PEGylated), an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A. Adynovate is built on the full-length Advate (antihemophilic factor (recombinant))molecule, a treatment for hemophilia A by Baxalta.

Through a collaboration with Nektar Therapeutics, Adynovate uses proprietary pegylation technology designed to prolong the amount of FVIII available for use in the body. The technology was selected because it maintains the integrity of the parent molecule (Advate) and reduces the speed at which the body clears Adynovate, resulting in increased circulating half-life.

In addition to the patents relating to pegylated FVIII, Baxalta has an exclusive license in the field of hemophilia to certain other patents relating to pegylated FVIII proteins. These patents protect Baxalta's pipeline of extended circulating half-life FVIII products, including Adynovate.

Source: Baxalta

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