Galderma announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting the marketing authorization of Nemolizumab for the treatment of both atopic dermatitis and prurigo nodularis in the European Union (EU). The CHMP has recommended Nemolizumab’s approval for subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy, and for subcutaneous use for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. This follows its approval for the treatment of adults with prurigo nodularis by the United States (U.S.) Food and Drug Administration (FDA) in August 2024.

Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease with up to 66% of adults suffering with a moderate-to-severe form of the condition. Often reported as one of patients’ most problematic symptoms, 87% of people with atopic dermatitis say they are seeking freedom from itch. Atopic dermatitis is also a highly heterogenous disease and can be associated with several comorbid conditions, namely mental health disorders and other autoimmune- or immune-mediated diseases. Prurigo nodularis is a serious skin condition characterized by several debilitating symptoms, including chronic itch, skin nodules covering large body areas, and poor sleep quality.

This positive opinion from the CHMP follows the U.S. FDA’s approval of Nemolizumab (marketed as Nemluvio®) as a pre-filled pen for subcutaneous injection for the treatment of adults. The U.S. FDA’s review of Galderma’s Biologics License Application for Nemolizumab for the treatment of moderate-to-severe atopic dermatitis is currently ongoing. Galderma also has marketing authorization applications for Nemolizumab in both atopic dermatitis and prurigo nodularis under review by multiple additional regulatory authorities in countries such as Australia, Singapore, Canada , Switzerland, Brazil, and South Korea. Further submissions to other regulatory authorities will continue throughout the coming months.