Vanda Pharmaceuticals said on Monday the European Commission designated imsidolimab as an orphan medicinal product for the treatment of generalized pustular psoriasis (GPP), a rare inflammatory skin disorder.
The designation, granted based on a positive opinion from the European Medicines Agency’s Committee for Orphan Medicinal Products, marks the first EU orphan recognition for a GPP therapy. Vanda holds exclusive global rights to develop and commercialize imsidolimab, a fully humanized IgG4 monoclonal antibody that inhibits IL-36 receptor signaling.
The company noted that orphan designation in the EU provides protocol assistance, reduced regulatory fees, and 10 years of market exclusivity upon approval. The prevalence threshold for EU orphan designation requires the condition to affect fewer than five in 10,000 people in the region.
Vanda previously secured orphan drug designation for imsidolimab from the U.S. FDA and Japan’s Ministry of Health, Labour and Welfare. The drug is currently under review by the FDA, with a target action date of December 12, 2026 for its Biologics License Application in GPP.
Dr. Mihael H. Polymeropoulos, Vanda’s president, CEO and chairman, said the EU designation represents a key milestone for patients with GPP and supports the company’s efforts to bring the investigational therapy to European patients.
