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EC grants orphan drug designation to imsidolimab for GPP
On August 24, 2026, the European Commission (EC) granted orphan drug designation to imsidolimab, a monoclonal antibody targeting interleukin (IL)-36 signaling, for the treatment of generalized pustular psoriasis (GPP).1
This designation was based on the positive opinion received from the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP).1 Orphan drug designation has also previously been granted to imsidolimab for the treatment of GPP by the U.S. Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare.1
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