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Shire plc, a leading global biotechnology company, announced that the US Food and Drug Administration (FDA) has approved the Baxject III reconstitution system for Adynovate [Antihemophilic Factor, (Recombinant), PEGylated].
The new system reduces the number of steps in the reconstitution process for hemophilia A patients and caregivers. Adynovate and the diluent will be pre-packaged in the Baxject III reconstitution system.
“At Shire our focus is always on the patient, so we're pleased to provide our hemophilia A patients with a new option that will enable them to prepare their treatment with fewer steps,” said Perry Sternberg, head of US Commercial, Shire. “Streamlining the process may minimize opportunities for reconstitution errors, helping to ensure patients can get the full benefit of their treatment.”
The Baxject III reconstitution system reduces the number of steps in the treatment process by two, compared to the previous process with the Baxject II Hi Flow Needleless transfer device. The Baxject III 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 1000 IU potencies; and a 5 mL diluent for the 2000 IU potency.
Adynovate, an extended circulating half-life recombinant Factor VIII (rFVIII) treatment built on the proven protein of Advate [Antihemophilic Factor (Recombinant)], was approved by the FDA in November 2015 for use in hemophilia A patients 12 years 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.
