FDA Approves Easier Preparation System for Hemophilia A Patients on Adynovate Therapy

Shire recently announced that the U.S. Food and Drug Administration (FDA) has approved its Baxject III reconstitution system for Adynovate, an approved treatment for Hemophilia A. This system will allow patients and caregivers to prepare the therapy with fewer steps, minimizing the chances for possible errors.

Adynovate is a recombinant Factor VIII (rFVIII) treatment with an extended half-life. Developed by Baxalta, the former BioScience division of Baxter and now part of Shire, Adynovate was built on the proven protein Advate [Antihemophilic Factor (Recombinant)], and it was approved by by the FDA in November 2015 for use in hemophilia A patients, 12 years and older, to control bleeding episodes and for routine prophylaxis, a preventive treatment to reduce the frequency of their occurrence.

The Baxject III reconstitution system, compared to the Baxject II Hi Flow Needleless transfer device, reduces the number of steps in the treatment process by two. Adynovate and the diluent will be pre-packaged in the new system, which will become available to most patients and caregivers in late 2016. Adynovate will be come with a 2 mL diluent for the 250, 500, and 1000 IU potencies, and a 5 mL diluent for the 2000 IU potency.

Adynovate offers a simple, twice a week dosing schedule, with most patients not needing an adjustment in their starting prophylaxis dose. The one-piece Baxject devices are a needle-free way of reconstituting the protein medicine. Reconstitution of a protein refers to the process of restoring the biological substance form, which was altered for purposes of storage and preservation. Several educational videos are available for patients and caregivers on the company’s website.

“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,” Perry Sternberg, head of U.S. Commercial, Shire, said in a press release. “Streamlining the process may minimize opportunities for reconstitution errors, helping to ensure patients can get the full benefit of their treatment.” In early 2016, Baxalta filed an application for the approval of Adynovate to be used in pediatric and surgical settings in the United States.