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news.Baxter International has submitted a new drug application (NDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) seeking approval for BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment based on ADVATE for patients over 12 years of age with hemophilia A.
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ADVATE is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A for control and prevention of bleeding episodes, perioperative management as well as routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
The NDA is based on positive results from a prospective, global Phase III trial of 137 previously treated patients (PTP).
The results showed that BAX 855 met its primary endpoint in the control and prevention of bleeding episodes and routine prophylaxis for patients who were 12 years or older.
In late 2014, the company had submitted an NDA to the US Food and Drug Administration (FDA).
Baxter BioScience vice-president and global head of research and development John Orloff said: "We continue to advance BAX 855 as a potential new treatment for hemophilia A patients around the world who are seeking options that support their individual needs.
"With more than a decade of experience with ADVATE and an extensive global presence, our BAX 855 program represents our continued commitment to supporting the hemophilia community, particularly this week as we celebrate World Hemophilia Day with our colleagues around the globe."
The company continues to advance a continuation trial for patients who completed the pivotal trial and a Phase III study among previously treated patients under the age of 12 with severe hemophilia A.
Following completion of the pediatric study, the company intends to file for marketing authorization with the European Medicines Agency (EMA) in 2016 and intends to seek post-approval label expansion in the US for previously-untreated pediatric patients.