Gliknik announced that its licensee, Pfizer, has received notification from the 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 based on Pfizer data reviewed by the FDA.

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In contrast to other IVIG blood products, GL-2045 is a recombinant (not blood derived) IVIG that may provide patients an equally effective alternative but potentially more convenient and safer without the risk of blood-borne pathogens.

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