The US FDA has approved Baxter Healthcare Corporation's new 2000 IU (5mL) Ultra-High dosage of ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM)], the only therapy free of blood-based additives, used for the prevention and control of bleeding episodes in people with haemophilia A.
According to the company release, the new Ultra-High dosage strength vial makes it easier for people requiring higher doses to administer ADVATE by reducing both the infusion volume of drug solution and the storage space. The therapy will be available to patients in the United States by the end of May.
As each person with haemophilia has different needs when it comes to their infusions, it is important for them to have a variety of dosage strengths from which to choose. With the approval of the Ultra-High dosage strength, ADVATE is now the only factor VIII therapy to offer people with haemophilia A in the United States five different dosage strengths: Low (250 IU), Medium (500 IU), High (1000 IU), Super-High (1500 IU) and Ultra-High (2000 IU).
"We heard from the community that there was a need for more choices in dosage strengths for haemophilia therapies," Joy Amundson, president, Baxter's BioScience business said adding, "Therefore, we are proud to offer the Ultra-High dosage strength of ADVATE, providing patients with one more reason to choose ADVATE, the therapy people with haemophilia have come to rely on."
ADVATE is currently approved for use in the United States, Australia and 14 countries in the European Union.