Pharma/Biotech Update: Baxter Submits Application to FDA
December 1, 2014; Posted by: WeBleed staff
Baxter International submits FDA application for new hemophilia A drug.
According to an article today by Ellen Jean Hurst of the Chicago Tribune, Baxter International submitted an application to the Food and Drug Administration (FDA) for the approval of BAX 855, an extended-release version of its flagship hemophilia drug Advate.
“The evidence from our late-stage controlled trial showcases that BAX 855 could become an important new treatment option for people with hemophilia A, expanding on more than a decade of experience with Advate,” said Dr. John Orloff, vice president and global head of research and development for Baxter BioScience. ”BAX 855 represents our continued commitment to developing valuable new options for the hemophilia community that address the needs of patients around the world.”
The primary goal of a recently completed clinical trial showed that the drug reduces bleeding rates in patients “who are administered the drug on a preventive basis versus on-demand treatment” and when the drug is issued twice weekly on a preventive basis, annualized bleed rates were reduced by 95 percent.
2015 and 2016 are forecasting to have big releases of new factor medications.
Photo Credit – Baxter International
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