Galderma 'Nemluvio' for atopic dermatitis·PN wins nod in KOR

Monoclonal antibody that selectively blocks the interleukin (IL)-31

Demonstrated improvement of itching·dermatological symptoms·insomnia through clinical trials

Product photo of Nemluvio

Galderma Korea (CEO Jaihyuk Lee) announced that Nemluvio (nemolizumab), a biologic that selectively blocks the interleukin (IL)-31 receptor, received domestic approval on the 23rd for the treatment of moderate-to-severe atopic dermatitis and prurigo nodularis.

With this approval, Nemluvio has become the only treatment option for moderate-to-severe atopic dermatitis that allows the dosing interval to be extended to every eight weeks, reducing the treatment burden on patients by reducing the frequency of administration.

Nemluvio is the world's first monoclonal antibody that selectively blocks IL-31 receptor alpha, thereby inhibiting the IL-31 signaling pathway. IL-31 ia primary cause of itching.

IL-31 is a neuro-immune cytokine that induces repetitive scratching behavior by directly stimulating nerves and activating sensory neurons that transmit itch signals. In addition to triggering itch, it serves as a quadruple trigger deeply involved in the fundamental pathophysiology of atopic dermatitis and prurigo nodularis, including inflammatory expression, epidermal dysregulation, and skin fibrosis.

The basis of Nemluvio approval was the results of the Phase 3 ARCADIA and OLYMPIA clinical trials.

ARCADIA 1 and 2 were randomized, double-blind, placebo-controlled, global Phase 3 clinical studies conducted in 941 and 787 patients, respectively, aged 12 and older with moderate-to-severe atopic dermatitis, to evaluate the efficacy and safety of Nemluvio over 48 weeks.

The clinical results showed that Nemluvio+topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI), met all endpoints compared to the placebo group.

The proportion of patients achieving at least 75% improvement in the Eczema Area and Severity Index (EASI-75) was 43.5% and 42.1% in the Nemluvio+TCS/TCI treatment groups in the ARCADIA 1 and 2 studies, respectively, compared to 29% and 30.2% in the placebo groups, demonstrating a statistically significant difference between the two groups.

In particular, a statistically significant difference in pruritus compared to the placebo group was observed starting from 48 hours after administration, confirming Nemluvio's rapid itch-relief effect. At weeks 4 and 16, more than twice as many patients in the Nemluvio+TCS/TCI group experienced clinically meaningful itch relief (PP-NRS improvement of 4 points or more) compared to the placebo group.

OLYMPIA 1 and 2 were conducted on 286 and 274 adult patients, respectively, aged 18 and older, with moderate-to-severe prurigo nodularis. In these trials, Nemluvio monotherapy met all endpoints compared to the placebo group.

Nemluvio demonstrated a consistent safety profile across all clinical programs. The incidence of serious adverse events (SAE) was similar to that of the placebo group, and most adverse events were mild to moderate and manageable.

Yang Won Lee, President of the Korean Atopic Dermatitis Association (Department of Dermatology, Konkuk University Hospital), explained, "Atopic dermatitis and prurigo nodularis are chronic inflammatory neuro-immune diseases where symptoms such as 'itching' cause chronic insomnia, fatigue, and various psychological stresses, seriously degrading the quality of life for patients."

Lee added, "With the introduction of a new biologic targeting the IL-31 receptor, a key pathway for itching, to the domestic market, we hope to alleviate the suffering of patients with moderate-to-severe atopic dermatitis and prurigo nodularis and see another meaningful advancement in long-term disease management."

CEO Jaihyuk Lee, stated, "Based on our long-standing expertise in the field of dermatology, Galderma has introduced a new biological treatment option that can meet the unmet medical needs of patients with atopic dermatitis and prurigo nodularis. We expect Nemluvio, the first to directly inhibit the interleukin-31 pathway, to provide patients with more effective and sustainable treatment opportunities and bring substantial changes to their daily lives."

Galderma Korea plans to launch Nemluvio in the second half of this year. The company has completed the application for health insurance reimbursement listing to secure faster access to treatment for patients with atopic dermatitis and prurigo nodularis.