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Bio Products Laboratory Ltd.

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

Date added: Friday 29th May 2015
Latest updated: Wednesday 8th February 2017

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/

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