Baxter International submitted an application to the Food and Drug Administration for the approval of a key hemophilia drug.
The drug, BAX 855, is an extended-release version of its flagship hemophilia drug Advate, which is sold in dozens of countries. The treatment is seen as a key part of the company’s drug pipeline and its multibillion dollar hemophilia franchise.
“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.”
Hemophilia A is a genetic disorder caused by certain missing or defective clotting agents in the blood. About 20,000 Americans suffer from the disorder, according to the National Hemophilia Foundation.
In August, the Deerfield-based company said the drug met its primary goal in a late-stage clinical study. The primary goal of the clinical trial was to show that the drug reduces bleeding rates in patients who are administered the drug on a preventive basis versus on-demand treatment.
Baxter, said when the drug is issued twice weekly on a preventive basis, annualized bleed rates were reduced by 95 percent.
The company is recruiting patients for a late-stage clinical trial to test the drug in children ages 12 and younger.
Also Monday, Pfizer said it has completed the $635 million acquisition of Baxter’s commercial vaccines business.
Baxter shares fell slightly during morning trading.
This story was originally posted in the Chicago Tribune on Wednesday, December 3, 2014. Read it in its entirety.
Read the press release that Baxter International released on December 1, 2014.Â