DEERFIELD (dpa-AFX) - Baxter International Inc. (BAX) said the U.S. Food and Drug Administration or FDA has approved a new reconstitution system for Antihemophilic Factor [Recombinant] or ADVATE. ADVATE and the diluent come pre-packaged in the new BAXJECT III reconstitution system.
'ADVATE has the widest range of dosage formulations, allowing for more precise customized dosing, and with the ADVATE with BAXJECT III reconstitution system, patients can prepare their treatment with fewer steps,' said Ludwig Hantson, president of Baxter BioScience.
According to the company, the new reconstitution system was developed to reduce the number of steps in the reconstitution process for hemophilia A patients and caregivers, compared with the earlier process with the BAXJECT II needle-less transfer device. In the coming months, the new system would be commercially available with ADVATE. Also, Baxter has filed for approval of ADVATE with BAXJECT III system in Europe and expects the launch in 2015.
In a human factors study performed with 44 participants, including patients, caregivers and healthcare providers, the firm assessed the usability of ADVATE with BAXJECT III reconstitution system. The BAXJECT III reconstitution system achieved its performance goals in the trial, as it was considered adequately safe and effective for its intended use, the company said.
ADVATE is indicated for the control and prevention of bleeding episodes in adults and children with hemophilia A.
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