Gliknik Inc., a privately held biopharmaceutical company, today announced that its licensee Pfizer Inc. (NYSE: PFE) has received notification from the U.S. Food and Drug Administration (FDA) that its autoimmune candidate drug GL-2045, a recombinant Intravenous Immune Globulin (IVIG)-mimetic, has been granted orphan drug designation for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a rare neurological disorder characterized by progressive weakness and impaired sensory function in the legs and arms.
GL-2045 received the Orphan Drug designation for CIDP under the U.S. Orphan Drug Act following a review by the FDA of a package of data submitted by Pfizer. The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs or biologics that treat a disease or condition affecting fewer than 200,000 patients in the U.S.
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