Galderma Announces Updates on Nemolizumab Development

TOKYO, February 15, 2024 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that Galderma issued a press release on February 14 that the U.S. Food and Drug Administration (FDA) has accepted Galderma’s Biologics License Applications (BLA) for a humanized anti-human IL-31 receptor A monoclonal antibody nemolizumab for the treatment of patients with prurigo nodularis (PN) and for adolescents and adults with moderate to severe atopic dermatitis, with a priority review designation for PN. It was announced by Galderma, that the European Medicines Agency (EMA) has also accepted the Marketing Authorization Applications for nemolizumab in prurigo nodularis and atopic dermatitis. Nemolizumab was created by Chugai, and its clinical development outside Japan is being conducted by Galderma. Please refer to the link below for details of the Galderma’s press release: Galderma announces regulatory filing acceptance for nemolizumab in prurigo nodularis and atopic dermatitis in the U.S. and EU https://www.galderma.com/news/galderma-announces-regulatory-filing-acceptance-nemolizumab-prurigo-nodularis-and-atopic

The release as fetched from its publisher. chugai-pharm.co.jp ↗