Imsidolimab functions by inhibiting the interleukin-36 receptor signaling pathway, effectively addressing the receptor antagonist deficiency common in patients suffering from this life-threatening condition. By securing this designation, Vanda gains access to protocol assistance, reduced regulatory fees, and future market exclusivity within the European Union.

Dr. Mihael H. Polymeropoulos, CEO of Vanda, described the decision as a critical milestone that validates the clinical data supporting the program and addresses a significant unmet medical need. The company is simultaneously pursuing regulatory pathways elsewhere, with the FDA currently reviewing a Biologics License Application for imsidolimab that carries a target action date of December 12, 2026.