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FDA Accepts BPL’s Amended BLA Submission for Coagadex®
(Coagulation Factor X, Human)


ELSTREE, UK AND DURHAM, NC - May 27, 2015 – Bio Products Laboratory, Ltd. (BPL), 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.

 

About Bio Products Laboratory, Ltd.

Bio Products Laboratory, Ltd. (BPL) is a leading manufacturer of plasma-derived protein therapies with global headquarters in Elstree, England, US headquarters in Durham, NC, and a presence in more than 45 countries worldwide.  The company has over 60 years of experience developing and manufacturing plasma-derived therapies since being established as part of the Lister Institute in 1950, and currently markets a wide range of products including coagulation factors, human immunoglobulins, and albumin.  BPL is committed to continued investment in research and development to maintain its key position as a reliable supplier of high-quality products to patients and healthcare providers worldwide.

 

LINKS:


http://www.factorxinfo.com

http://www.bpl.co.uk/about-bpl
http://www.bpl-us.com