Baxter Announces FDA Approval Of ADVATE 4000 IU Dosage Strength

Baxter International Inc. (NYSE:BAX) today announced that the U.S. Food and Drug Administration (FDA) has approved a new 4000 IU dosage strength of ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method]. ADVATE is a full-length recombinant factor VIII (FVIII) product that is indicated for the control and prevention of bleeding episodes in patients with hemophilia A. The new 4000 IU dosage strength provides the convenience of a single vial dosing opportunity for many adult patients, including some patients on a dosing schedule of every three days for prophylactic treatment with ADVATE.

This approval extends Baxter’s portfolio of hemophilia treatments, and makes Baxter the only company to offer a 4000 IU dosage. This broad selection of 11 dosages enhances convenience for patients by offering the opportunity to use a single vial rather than infusing multiple vials of therapy. The 4000 IU will be available to patients in the United States in August.

''The 4000 IU dose is particularly well-suited for patients on an every three-day prophylaxis regimen,'' said Bruce Ewenstein, M.D., Ph.D, vice president, clinical affairs, Baxter’s BioScience business.

In December 2011, ADVATE was approved by the U.S. FDA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A, becoming the only antihemophilic recombinant FVIII treatment approved in the U.S. for prophylactic use in both adults and children (0-16 years). The approval was based on Phase IV data showing that routine prophylaxis of ADVATE significantly reduced median annual bleed rates (ABR) in hemophilia A patients from 44 to one as compared to an on-demand regimen, a 98 percent reduction in ABR. 42 percent of patients experienced no bleeding episodes while on one year of prophylactic treatment.

The serious adverse reactions seen with ADVATE are hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to FVIII. The most common adverse reactions observed in clinical trials (frequency ≥ 10 percent of subjects) were pyrexia, headache, cough, nasopharyngitis, vomiting, arthralgia, and limb injury.

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