Company Announces Regulatory Filing for Nemolizumab for Two Indications.

Galderma has announced that the FDA has accepted its Biologics License Application for nemolizumab, a monoclonal antibody, for the treatment of prurigo nodularis and moderate to severe atopic dermatitis in adolescents and adults. The drug has also been granted FDA Priority Review for prurigo nodularis. The European Medicines Agency has accepted Galderma's Marketing Authorization Applications for both indications as well. These regulatory developments are based on data from the phase III OLYMPIA clinical trial program, which showed significant improvements in itch intensity and skin lesions in patients treated with nemolizumab compared to placebo. [Extracted from the article]