CHMP Recommends Approval of Galderma’s Nemolizumab for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis in the European Union

Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease characterized by persistent itch and recurrent skin lesions, and affects approximately up to 40 million people in the European Union (EU)1-4
Prurigo nodularis is a serious skin disease characterized by chronic itch, skin nodules covering large body areas, and poor sleep quality, which is estimated to affect up to 111 people per 100,000 in the EU5-10
Nemolizumab is a first-in-class monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.2 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in both atopic dermatitis and prurigo nodularis11-13
This positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommending the granting of marketing authorization of nemolizumab in the European Union (EU) for the treatment of both atopic dermatitis and prurigo nodularis follows the United States Food and Drug Administration’s approval of nemolizumab for the treatment of adults with prurigo nodularis earlier in August 202414

ZUG, Switzerland--(BUSINESS WIRE)--Galderma today 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 2024.14

Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease which affects approximately 10 to 40 million people in the EU, with up to 66% of adults suffering with a moderate-to-severe form of the condition.1-4,15 Often reported as one of patients’ most problematic symptoms, 87% of people with atopic dermatitis say they are seeking freedom from itch, with speed of itch relief therefore also prioritized by both patients and physicians.16-19 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.20,21

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.5-7,10 The condition is underrecognized and underdiagnosed, and its prevalence is not well-documented, but it is estimated to affect between 7-111 people per 100,000 in the EU depending on the country.8,9,12

Given the significant burden these serious diseases place on patients, their families, and caregivers, there is a need for alternative treatment options that may effectively relieve the signs and symptoms.22,23