ZUG, SWITZERLAND -- 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.[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]

“The robust evidence base we have built for nemolizumab in both atopic dermatitis and prurigo nodularis shows the extent of its potential in improving outcomes for these diseases where the burden and unmet needs remain high. We now await the European Commission’s approval decision and hope to be able to bring nemolizumab to patients in the European Union in due course.”

FLEMMING ØRNSKOV, M.D., MPH CHIEF EXECUTIVE OFFICER GALDERMA

This positive CHMP opinion is based on robust results from the phase III ARCADIA and OLYMPIA clinical trial programs in atopic dermatitis and prurigo nodularis, respectively.

The phase III ARCADIA 1 and 2 trials evaluated the efficacy and safety of nemolizumab in 1,728 adolescent and adult patients with moderate-to-severe atopic dermatitis. Results demonstrated that patients treated with nemolizumab, administered subcutaneously every four weeks in combination with background topical corticosteroids (TCS), with or without topical calcineurin inhibitors (TCI), showed statistically significant improvements in co-primary and key secondary endpoints, when compared to placebo in combination with TCS, with or without TCI, after 16 weeks of treatment, with significant itch relief observed as early as Week 1.[24]

The phase III OLYMPIA 1 and 2 trials evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks in more than 500 patients with prurigo nodularis. The trials met both their primary and key secondary endpoints, demonstrating that treatment with nemolizumab resulted in significant and clinically meaningful improvements in itch and skin nodules at Week 16, with rapid reductions in itch observed as early as Week 4.[25,26]

Nemolizumab was well tolerated in both trials, and its safety profile was generally consistent with earlier data, and between trials.[24-26]

The positive CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorization. If approved, nemolizumab would be the first monoclonal antibody treatment available for patients in the EU 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 nodularis.[11-13]

“This positive opinion represents an encouraging step forward for patients in the EU with atopic dermatitis and prurigo nodularis, given the profound impact these conditions have on the lives of patients and their loved ones. With unrelenting itch, accompanied by skin lesions as well as potential mental health implications, new treatment options that have the potential to quickly and effectively treat these conditions are essential.”

PROFESSOR DIAMANT THAÇI LEAD INVESTIGATOR OF THE ARCADIA LONG-TERM EXTENSION STUDY UNIVERSITY OF LUBECK, GERMANY

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 with prurigo nodularis in August 2024.[14] 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, with a decision anticipated soon. Galderma also has marketing authorization applications for nemolizumab in both atopic dermatitis and prurigo nodularis under review by multiple additional regulatory authorities, including via the Access Consortium framework in countries such as Australia, Singapore, and Switzerland, as well as in Canada, Brazil, and South Korea. Further submissions to other regulatory authorities will continue throughout the coming months.