Vanda Pharmaceuticals Receives Orphan Drug Designation in Japan
Vanda Pharmaceuticals announced that Japan's Ministry of Health, Labour and Welfare has granted orphan drug designation to imsidolimab, a high-affinity humanized immunoglobulin G4 monoclonal antibody, for the treatment of generalized pustular psoriasis. The MHLW grants orphan drug designation to medicines intended to treat rare diseases with significant unmet medical need. In Japan, approximately 2,200 people have been diagnosed with GPP. In Japan, orphan drug designation provides development incentives, including subsidies for research and development costs, as well as the potential for up to 10 years of market exclusivity following approval. This designation follows similar regulatory recognition in the U.S.
