FDA Accepts BPL’s Amended BLA Submission for Coagadex® (Coagulation Factor X, Human)
ELSTREE, U.K. & DURHAM, N.C.–(BUSINESS WIRE)–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.
Source: Business Wire Health