A Japanese subsidiary of Baxter International Inc has submitted a regulatory application to the Minister for Health, Labour and Welfare to request approval in Japan to market Advate Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM) for the treatment of haemophilia A.

The submission was made through the local regulatory process, which will include an evaluation by the Pharmaceuticals and Medical Devices Agency (PMDA). This is the first step in gaining regulatory approval for Advate in Japan.

The regulatory submission in Japan included results from a global, multi-centre, randomized, double-blind, cross-over study comparing the pharmacokinetics of Advate and Recombinate Antihemophilic Factor (Recombinant) rAHF, a leading recombinant Factor VIII therapy that has been available from Baxter since 1992. Results from a local clinical study conducted in Japan were also included, Baxter said in a release.

Advate is the only haemophilia A therapy made without any plasma protein additives in the cell culture process, purification and final formulation, thereby eliminating the risk of infection from viruses and infectious prions that may be carried in these protein additives.

Bruce Ewenstein, global medical director for Baxter's BioScience business said, "Based on the volume of Advate in the marketplace, and the reporting of patient experience with the product, we have seen results that continue to support the safety and efficacy of Advate and confirm what was documented in clinical trials."

Following its approval in July 2003 in the United States and subsequently in the European Union, Advate has been widely accepted by patients and clinicians. Through September 2004, more than 225 million international units of Advate have been distributed worldwide. In just the first year following availability of the product in the United States, more than 150 million international units of Advate were distributed worldwide. This is more than twice the distribution within a similar post-launch time frame for Recombinate, which went on to become a leading recombinant Factor VIII concentrate. In the first 12-months post-launch for Recombinate, 69 million international units were distributed, Baxter said.