Hemophila A patients can now prepare for their treatment with lower number of steps in the reconstitution process from the new FDA approval on the the Baxject III reconstitution system for adynovate. ,Buyers will recieve adynovate and the diluent will be prepackaged in the Baxject III reconstitution system and a quicker step process for treatment compared to the old model.
Adynovate is an extended circulating half-life recombinant factor VIII (rFVIII). It was built on the proven protein of Advate (antihemophilic factor [recombinant], Baxalta). It is designed for adolescent and adult patients 12 years of age and older diagnosed with hemophilia A for the on-demand treatment and control of bleeding episodes and for routine prophylaxis to reduce the frequency of bleeding episodes.
Neutralizing Antibodies is a key benefit from this. Neutralizing antibodies (inhibitors) have been reported following administration of advate predominantly in previously untreated patients (PUPs) and previously minimally treated patients (MTPs).
The Baxject III is a needless transfer device. The approved Baxject III reconstitution system reduces the number of steps in the treatment process by two, and now takes about half the time as compared with the BAXJECT II transfer device.
With a lessened step process for treatment, Shire hopes more patients and caregivers will purchase the product for their on-demand treatments.
Hemophilia A is a rare, chronic, genetic disorder that results in impaired clotting mechanisms due to missing or reduced levels of factor VIII. People with hemophilia A experience recurrent and extended bleeding episodes that cause pain and irreversible joint damage. Some of these bleeding episodes can be life threatening. There are an estimated 16,000 – 20,000 people in the United States with hemophilia A (and 142,000 world wide).