Baxter Submits New Drug Application To Japan's MHLW For Approval Of BAX 855

(RTTNews) - Baxter International Inc. (BAX) announced that it has submitted a new drug application or NDA to Japan's Ministry of Health, Labour and Welfare for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII or rFVIII treatment based on ADVATE for patients over 12 years of age with hemophilia A.

The submission follows the filing to the United States Food and Drug Administration or FDA in late 2014 and is based on positive results from a prospective, global, Phase 3 study of 137 previously treated patients, the company said.

The results, presented during the European Association for Haemophilia and Allied Disorders or EAHAD meeting in February 2015, demonstrated 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.

Baxter continues to advance a continuation study for patients who completed the pivotal trial and a Phase 3 study among previously treated patients under the age of 12 with severe hemophilia A. Once the pediatric study has been completed, the company expects to file for marketing authorization with the European Medicines Agency in 2016 and intends to seek post-approval label expansion in the U.S. for previously-untreated pediatric patients.

BAX 855 is based on ADVATE, a full-length FVIII molecule with more than 12 years of real-world experience. Through a collaboration with Nektar Therapeutics (NKTR), BAX 855 leverages proprietary pegylation technology designed to extend the duration of activity of the protein in the body. This proprietary technology has been used for over 10 years in a number of approved medicines that treat chronic or serious conditions, Baxter stated.