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FDA Approves Reconstitution System for Hemophilia Treatment Adynovate
The FDA has approved the Baxject III reconstitution system for Adynovate (antihemophilic factor [recombinant], PEGylated, Shire). The new system reduces the number of steps in the reconstitution process for patients with hemophilia A and their caregivers. Adynovate and the diluent will be prepackaged in the Baxject III reconstitution system.
The Baxject III system reduces the number of steps in the treatment process by two, compared with the previous process with the Baxject II Hi Flow Needleless transfer device. The system with Adynovate will be available to most customers in the fourth quarter of 2016, with a 2-mL diluent for the 250-, 500-, and 1,000- IU potencies; and a 5-mL diluent for the 2,000-IU potency.
Adynovate, an extended circulating half-life recombinant factor VIII (rFVIII) treatment built on the proven protein of Advate (antihemophilic factor [recombinant], Baxalta), was approved by the FDA in November 2015 for use in hemophilia A patients 12 years of age and older for on-demand treatment and control of bleeding and for prophylaxis to reduce the frequency of bleeding episodes. In early 2016, Baxalta, now part of Shire, filed for use in pediatric and surgical settings in the United States.
Adynovate is a human antihemophilic factor indicated for adolescent and adult patients (12 years of age and older) with hemophilia A (congenital factor VIII deficiency) for the on-demand treatment and control of bleeding episodes and for routine prophylaxis to reduce the frequency of bleeding episodes. Adynovate is not indicated for the treatment of von Willebrand disease.
Source: Shire; August 1, 2016.