Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced that the European Commission has granted Orphan Designation to its investigational drug imsidolimab for the treatment of Generalized Pustular Psoriasis (GPP), a rare inflammatory skin disease.

According to the company's press release, this marks the first time the European Commission has granted orphan designation for a drug targeting GPP in the European Union. The designation followed a positive opinion from the European Medicines Agency's Committee for Orphan Medicinal Products.

GPP is characterized by widespread pustular eruptions, systemic inflammation, and complications that can lead to increased mortality. Imsidolimab inhibits IL-36 receptor signaling, which is implicated in the disease.

EU Orphan Designation is granted for medicines targeting conditions affecting fewer than 5 in 10,000 people. Benefits include protocol assistance, reduced regulatory fees, and market exclusivity provisions upon approval.

The U.S. Food and Drug Administration and Japan's Ministry of Health, Labour and Welfare had previously granted imsidolimab Orphan Drug Designation for GPP. The imsidolimab Biologics License Application currently under FDA review carries a target action date of December 12, 2026.

Vanda holds an exclusive global license for the development and commercialization of imsidolimab, with regulatory and patent exclusivity expected to extend into the late 2030s.