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European Medicines Agency Approves SmPC Change To Baxter’s ADVATE To Include Information On PK-Guided Dosing Study

Baxter International Inc. (NYSE:BAX) today announced that the European Medicines Agency has authorized an update to the Summary of Product Characteristics (SmPC) for Baxter's ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin Free Method, (in the EU, ADVATE, octocog alfa)] to include findings of the Phase IV prophylaxis study.

The pharmacodynamic properties section of the updated European SmPC now describes the findings of an ADVATE Phase IV prophylaxis study that compared standard and pharmacokinetic (PK)-guided prophylaxis dosing regimens to on-demand treatment with ADVATE. PK-guided prophylaxis is based on each individual’s response to clotting factor. In the study (which supported the approval of the prophylactic dosing of ADVATE in the United States in 2011), of the two prophylactic regimens evaluated, the pharmacokinetic-driven regimen offered some patients the option of a dosing schedule of every three days. The clinical data demonstrated that PK-driven and standard prophylactic dosing regimens were comparably effective in reducing annual bleeding rates (ABR). 1

''Importantly, this addition to our ADVATE SmPC offers clinicians and patients in Europe information about pharmacokinetics that may enable them to better personalize their treatment regimens with the goal of fewer infusions per year while still effectively reducing bleeds,'' said Anders Ullman, M.D., Ph.D., vice president of global research and development in Baxter’s BioScience business.

In the prophylaxis study, an individualized pharmacokinetic guided dosing regimen (within a range of 20 to 80 IU of factor VIII per kg body weight at intervals of 72 ± 6 hours, n=23) was compared with a standard prophylactic dosing regimen (20 to 40 IU per kg every 48 ±6 hours, n=30) in previously-treated patients with Hemophilia A. The results showed a 98 percent reduction in annual bleed rate compared to the previous on-demand treatment period; 42 percent of patients experienced zero bleeds during one year on either of the prophylaxis regimens.

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