Medgenics Receives Orphan Drug Designation from FDA for INFRADURE Biopump to Treat Hepatitis D
Medgenics, Inc. (NYSE: MDGN), the developer of BiopumpTM, a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that its INFRADURE™ Biopump has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for the treatment of hepatitis D. INFRADURE is the version of Medgenics' Biopump technology platform which produces interferon alpha, commonly used to treat hepatitis. This marks the first Orphan Drug Designation granted for treatment of a clinical indication using the Biopump.
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