FDA approves Shire’s haemophilia A treatment system
pharmafile | August 1, 2016 | News story | Manufacturing and Production, Research and Development | FDA, Shire, adynovate, baxject, haemophilia
Shire has announced that the Food and Drug Administration (FDA) has approved the baxject III reconstitution system for adynovate [antihemophilic factor, (recombinant), PEGylated], which will reduce the number of steps in the reconstitution process for haemophilia A patients and caregivers. Adynovate and the diluent will be pre-packaged in the baxject III reconstitution system.
Approved by the FDA in November 2015, adynovate is an extended circulating half-life recombinant factor VIII (rFVIII) treatment built on the proven protein of advate [antihemophilic factor (recombinant)] for use in haemophilia A patients. The baxject III reconstitution system removes two steps from the treatment process compared to the previous baxject II hi-flow needleless transfer device.
“At Shire our focus is always on the patient, so we’re pleased to provide our haemophilia A patients with a new option that will enable them to prepare their treatment with fewer steps,” said Perry Sternberg, head of US Commercial at 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 system with adynovate will be available in Q4 2016.
Matt Fellows
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