Galderma has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the marketing authorization of nemolizumab for the treatment of both atopic dermatitis and prurigo nodularis in the European Union (EU). The CHMP’s recommendation is for subcutaneous use of nemolizumab in patients aged 12 and older with moderate-to-severe atopic dermatitis and in adults with moderate-to-severe prurigo nodularis, who are candidates for systemic therapy. This follows the approval of nemolizumab for prurigo nodularis by the U.S. Food and Drug Administration (FDA) in August 2024.
Atopic dermatitis is a chronic, inflammatory skin condition that affects approximately 10 to 40 million people in the EU. Around 66% of adults experience a moderate-to-severe form of the condition. The disease is often characterized by persistent itching, which patients report as one of the most problematic symptoms. For many, prompt relief from itching is a critical concern. Atopic dermatitis is also associated with other health issues, such as mental health disorders and autoimmune diseases.
Prurigo nodularis, a serious and often debilitating skin disorder, is characterized by chronic itching, skin nodules, and poor sleep quality. While underdiagnosed and underrecognized, prurigo nodularis is estimated to affect between 7 and 111 people per 100,000 in the EU, varying by country. Both conditions significantly impact patients’ daily lives and require effective treatments that can address the underlying symptoms and improve quality of life.
The positive opinion from the CHMP is based on data from two Phase III clinical trial programs: ARCADIA and OLYMPIA. The ARCADIA trials evaluated nemolizumab in 1,728 patients with moderate-to-severe atopic dermatitis. Results showed that patients receiving nemolizumab every four weeks, in combination with topical corticosteroids (TCS), had statistically significant improvements in both primary and secondary endpoints. Notably, patients experienced significant relief from itching as early as Week 1. In the OLYMPIA trials, which involved more than 500 patients with prurigo nodularis, nemolizumab also demonstrated significant improvements in both itch and skin nodules, with rapid reductions in itching observed as early as Week 4.
Nemolizumab was well tolerated in both clinical trials, with a safety profile consistent with earlier studies. The positive CHMP opinion will now be reviewed by the European Commission, which is expected to make a final decision on the EU-wide marketing authorization. If approved, nemolizumab would be the first monoclonal antibody treatment in the EU specifically targeting IL-31 receptor alpha, a neuroimmune cytokine involved in itch, inflammation, and skin barrier dysfunction in both atopic dermatitis and prurigo nodularis.
Flemming Ørnskov, CEO of Galderma, expressed optimism about the potential of nemolizumab to address the unmet medical needs of patients with these conditions, citing the strong evidence from the clinical trials. Professor Diamant Thaçi, lead investigator of the ARCADIA long-term extension study, emphasized the importance of new treatments for these conditions, which can significantly affect patients’ lives and mental health.
In addition to the positive opinion in the EU, the U.S. FDA approved nemolizumab (marketed as Nemluvio®) for prurigo nodularis in August 2024. Galderma’s Biologics License Application for nemolizumab to treat moderate-to-severe atopic dermatitis is under review in the U.S. with a decision expected soon. The company is also pursuing marketing authorizations for nemolizumab in other countries, including Australia, Canada, Brazil, South Korea, and Switzerland.
Nemolizumab was originally developed by Chugai Pharmaceutical Co., Ltd., and in 2016, Galderma obtained exclusive global rights to its development and marketing (excluding Japan and Taiwan). In Japan, nemolizumab is marketed as Mitchga® and is approved for prurigo nodularis and pruritus associated with atopic dermatitis in pediatric and adult patients.
