Vanda Pharmaceuticals Inc. said the European Commission granted orphan medicinal product designation to its investigational therapy imsidolimab for the treatment of Generalized Pustular Psoriasis (GPP).
The designation, recommended by the European Medicines Agency’s Committee for Orphan Medicinal Products, covers medicines intended to treat life-threatening or chronically debilitating rare conditions affecting fewer than five in 10,000 people in the EU. Benefits include protocol assistance, reduced regulatory fees and a decade of market exclusivity upon approval.
Imsidolimab, a fully humanized IgG4 monoclonal antibody, targets the interleukin-36 receptor signaling pathway implicated in GPP. Vanda holds exclusive global rights to develop and commercialize the drug. The company previously secured orphan designations from the U.S. FDA and Japan’s Ministry of Health, Labour and Welfare for the same indication.
Vanda’s shares closed at $5.28 on August 21, down 1.86% for the session. The company’s U.S. Biologics License Application for imsidolimab has a target action date of December 12, 2026, with regulatory and patent exclusivity expected to extend into the late 2030s.
Dr. Mihael H. Polymeropoulos, Vanda’s President, CEO and Chairman, said the EU designation marks a key milestone for GPP patients and the company’s efforts to bring the therapy to market in Europe.
