Baxter International Inc. (NYSE:BAX) today announced that the U.S. Food and Drug Administration (FDA) has approved a new reconstitution system for ADVATE (Antihemophilic Factor [Recombinant]). 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, Ph.D., president of Baxter BioScience. ''This latest approval reflects Baxter’s ongoing leadership in investing and bringing new and innovative therapies to the market that meet the evolving needs of the hemophilia community.''
The new reconstitution system was developed to reduce the number of steps in the reconstitution process for hemophilia A patients and caregivers, compared to the previous process with the BAXJECT II needle-less transfer device. The new system will be commercially available with ADVATE in the coming months. Baxter has also filed for approval of ADVATE with BAXJECT III system in Europe and expects to launch in 2015.
A human factors study was performed with 44 participants, including patients, caregivers and healthcare providers, to evaluate the usability of ADVATE with BAXJECT III reconstitution system. The BAXJECT III reconstitution system successfully met its performance goals in the study, as it was considered adequately safe and effective for its intended use.
ADVATE (Antihemophilic Factor [Recombinant]) is indicated for the control and prevention of bleeding episodes in adults and children (0-16 years) with hemophilia A. ADVATE is also indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with hemophilia A. The product is not indicated for the treatment of von Willebrand disease.
ADVATE has a demonstrated efficacy and safety profile. ADVATE is a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives. Because no blood-derived components are added at any stage of the manufacturing process, the potential risk of transmitting pathogens that may be carried in blood-based additives is eliminated. There have been no confirmed reports of transmission of HIV, HBV or HCV with rFVIII treatments.