Baxter International has received the US Food and Drug Administration (FDA) approval for its 4000 IU dosage strength of Advate[Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method].
Advate is a full-length recombinant factor VIII (FVIII) product, used to control and prevent bleeding episodes in patients with hemophilia A.
Baxter's BioScience business clinical affairs vice president Bruce Ewenstein said, ''The 4000 IU dose is particularly well-suited for patients on an every three-day prophylaxis regimen.''
The approval expands Baxter portfolio of hemophilia treatments and the product will be available in US from August 2012.
The new 4000 IU dosage strength provides the convenience of a single vial dosing opportunity for many adult patients, according to the company.
The adverse reactions noted with Advate are hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to FVIII.
