Nemluvio forms a new pillar in dermatitis treatment

Approved for prurigo nodularis and atopic dermatitis in Korea… IL-31 inhibitor

Itch relief within 48 hours and long-term data secured…Clinical evidence highlighted

The arrival of a biologic with a new mechanism of action in the treatment fields of atopic dermatitis and prurigo nodularis is raising the possibility of a shift in treatment strategies.

In particular, ‘Nemluvio (nemolizumab),’ which directly blocks IL-31 signaling in these two conditions where severe itching is a key symptom, is expected to emerge as a new treatment option based on its rapid symptom-relief effect.

On the 13th, Galderma Korea held a media session at the Plaza Hotel in Jung-gu, Seoul, to commemorate the domestic approval of the biologic Nemlubio.

Nemluvio media session

Nemluvio is a monoclonal antibody that inhibits the IL-31 signaling pathway, which is considered a major driver of itch. It received approval as a treatment for atopic dermatitis and prurigo nodularis in Korea last January. Among biologics targeting these diseases, Nemluvio is the first IL-31 inhibitor.

IL-31 is known to be a key pathway in the ‘itch-scratch cycle,’ directly stimulating sensory nerves to transmit itch signals and triggering repetitive scratching behavior. Furthermore, it is identified as a major factor exacerbating the disease through a complex mechanism involving inflammatory responses, epidermal barrier dysfunction, and skin fibrosis.

Nemluvio demonstrated statistically significant itch relief compared to the placebo group within 48 hours of administration in both atopic dermatitis and nodular prurigo patients. Additionally, when used in combination with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI), it met all primary endpoints.

Specifically, in atopic dermatitis, the proportion of patients achieving at least a 75% improvement in the Eczema Area and Severity Index (EASI-75) was significantly higher than in the placebo group. In prurigo nodularis, at week 16, the proportion of patients achieving an Investigator’s Global Assessment (IGA) score of 0/1, meaning ‘clear or almost clear’ skin lesions, was more than three times higher than in the placebo group.

Professor Jung Eun Kim, Department of Dermatology, Catholic University of Korea, Eunpyeong St. Mary's Hospital

The long-term follow-up studies also showed sustained efficacy and safety. According to interim analyses of the long-term extension studies in atopic dermatitis (ARCADIA LTE, 104 weeks) and prurigo nodularis (OLYMPIA LTE, 100 weeks), the improvements observed in skin lesions, itch, sleep, and overall quality of life remained consistent for more than 2 years, with no new adverse reactions observed.

Based on this evidence, combination therapy with Nemluvio was also included in the 2025 U.S. atopic dermatitis treatment guidelines.

Jung Eun Kim, Professor of Dermatology at Catholic University of Korea Eunpyeong St. Mary's Hospital, said, “Among approved biologics, Nemluvio showed the fastest effect in improving itch. It also offers safety advantages, as no increase in side effects like conjunctivitis, which has been a concern with existing treatments, was observed.”

She continued, “The proportion of moderate-severity patients with atopic dermatitis is increasing compared to severe cases. This is especially meaningful as a treatment option in elderly patients, where safety is particularly important.”

Galderma Korea plans to launch Nemluvio in the second half of this year and has already applied for reimbursement listing.

Jai Hyuck Lee, General Manager of Galderma Korea, said, “Nemluvio directly inhibits IL-31, a key trigger of itch, and is expected to present a new treatment paradigm for patients who face limitations with existing therapies.”