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FDA approves Adynovate for hemophilia A
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The FDA today approved antihemophilic factor (recombinant), PEGylated for adults and adolescents aged at least 12 years with hemophilia A.
Antihemophilic factor (recombinant), PEGylated (Adynovate, Baxalta) is indicated for on-demand treatment and control of bleeding episodes, as well as for prophylaxis in patients with hemophilia A.
The product consists of a full-length coagulation Factor VIII molecule linked to polyethylene glycol, or PEGylated. This link makes the product last longer in the patient’s blood, which could decrease the number of injections necessary to reduce the frequency of bleeding compared with unmodified antihemophilic factor.
The FDA based its decision in part on the results of a clinical trial composed of 137 adults and adolescents aged at least 12 years. Researchers sought to compare the recommended routine prophylactic treatment regimen to on-demand therapy.
Karen Midthun
Results showed Adynovate effectively reduced the number of bleeding episodes during routine care. The product also effectively treated and controlled bleeding episodes without any safety concerns.
“The approval of Adynovate provides an important therapeutic option for use in the care of patients with hemophilia A and reduces the frequency of Factor VIII infusions needed to avoid bleeding,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release.