Galderma Receives Filing Acceptances for Nemolizumab in Prurigo Nodularis and Atopic Dermatitis in Four Additional Countries
Galderma has received filing acceptances for nemolizumab for the treatment of patients with prurigo nodularis and for adolescents and adults with moderate-to-severe atopic dermatitis in Australia, Singapore, Switzerland, and the United Kingdom, via the Access Consortium framework The U.S. Food and Drug Administration and European Medicines Agency also accepted filing submissions for nemolizumab for the treatment of prurigo nodularis and atopic dermatitis in February 2024, with U.S. decisions anticipated this year Further submissions to regulatory authorities in additional countries are ongoing ZUG, Switzerland — Galderma today announced that it has received filing acceptances for nemolizumab for the treatment of patients with prurigo nodularis and for adolescents and adults with moderate-to-severe atopic dermatitis in Australia, Singapore, Switzerland, and the United Kingdom, whose regulatory authorities are members of the Access Consortium. An approval decision is expected from the consortium next year. Nemolizumab is a therapy specifically inhibiting IL-31 signaling to provide safe and rapid relief from the most burdensome symptom of both skin conditions: itch. 1-7