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New Hemophilia A Product Given FDA Orphan Drug Status

June 9, 2015; Posted by: WeBleed staff

U.S. Food and Drug Administration announces orphan designation for Apitope’s new product.

PRNewswire released a statement from Dr. Keith Martin, CEO of Apitope, regarding today’s announcement from the U.S. Food and Drug Administration — “Following the Orphan Drug Designation by the European Medical Agency last year, we are very pleased to receive designation from the US FDA for ATX-F8-117. These designations emphasise the need for an effective treatment for hemophilia A patients developing Factor VIII inhibitors that occurs in approximately 30% of patients. This results in poor clotting of the blood leading to severe health issues. This orphan drug designation follows extensive pre-clinical evaluation and we look forward to advancing a clinical development program for this important medical condition.”

Apitope has recently completed the research work to confirm that the two peptides in ATX-F8-117, derived from Factor VIII (8), have the potential to treat and prevent inhibitor development in hemophilia A patients treated with Factor VIII.

Photo Credit – Apitope

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