Bio Products Laboratory, Ltd., a leading manufacturer of plasma-derived therapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s amended Biologics License Application for Coagadex for hereditary factor X deficiency.  The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 27, 2015.

Coagadex is an investigational, high purity human factor X concentrate that has received FDA orphan drug designation for the treatment of hereditary factor X deficiency. The FDA is currently reviewing data from two Phase III trials of Coagadex.  

Hereditary factor X deficiency is a rare bleeding disorder that affects approximately 400-600 patients in the United States.  Affected individuals often have inadequate amounts of circulating factor X, an important component of the coagulation system.  Factor X deficient patients are at increased risk of bleeding and need to be managed similarly to hemophilia patients. There is currently no factor X product specifically approved by the FDA for the treatment of patients with hereditary factor X deficiency.

In addition, BPL has submitted a Marketing Authorization Application to the European Medicines Agency that is also currently under review.

For more details, go to: http://www.bpl-us.com/factorXfda.html