Nemluvio emerges as new force in global atopic dermatitis market

First-half sales reach KRW 600 billion…up 230% year on year

Rapid itch relief drives growth…reimbursement process underway in Korea as well

Signs of change are emerging in the global atopic dermatitis treatment market. Galderma’s biologic ‘Nemluvio (nemolizumab)’ is rapidly gaining ground with its novel IL-31-targeting mechanism in a market long dominated by IL-4 and IL-13 inhibitors.

According to Galderma on the 25th, Nemluvio generated sales of USD 433 million (approximately KRW 600 billion) in the first half of this year, representing year-on-year growth of 230.5%. Since its US approval in 2024, the drug has posted cumulative sales of USD 908 million in approximately 2 years.

Backed by rapid itch relief and convenient dosing, Nemluvio is seeking reimbursed launch in Korea in the first half of next year. Its arrival is expected to affect the domestic treatment landscape for severe atopic dermatitis and prurigo nodularis.

Galderma more than doubles US sales forecast for Nemluvio

Galderma reported record first-half sales of USD 3.14 billion (approximately KRW 4.34 trillion) in 2026. Nemluvio was a major driver of this performance.

Sales in Galderma’s prescription medicine business surged 67.9% year on year to USD 848 million (approximately KRW 1.17 trillion). Nemluvio alone accounted for half (51.1%) of the division’s sales.

Changes in Nemluvio Sales (Unit: USD 1 million)

US prescribing of Nemluvio, the approved monoclonal antibody to target IL-31, is also expanding rapidly. Based on new prescriptions in the United States during June and July, Nemluvio captured approximately 42% of the prurigo nodularis market and approximately 9% of the atopic dermatitis market.

The principal approved treatments for prurigo nodularis are limited to Dupixent (dupilumab) and Nemluvio. In contrast, the atopic dermatitis market is intensely competitive, with multiple biologics including Dupixent, Ebglyss (lebrikizumab) and Adtralza (tralokinumab) as well as Janus kinase (JAK) inhibitors. Despite these differences in the competitive landscape, Nemluvio has rapidly established a presence in the atopic dermatitis market.

Dr. Flemming Ørnskov, CEO of Galderma, expressed confidence in Nemluvio’s blockbuster potential, projecting that “the product’s US sales alone would exceed USD 1 billion (KRW 1.417 trillion) in 2026.” Galderma has consequently more than doubled its forecast for Nemluvio’s peak annual sales to over USD 4 billion (approximately KRW 5.668 trillion).

An FDA review is currently underway to expand Nemluvio’s indication to include children aged 2 to 11 years with atopic dermatitis, potentially providing further room for growth.

Directly inhibits IL-31, a key driver of itch…delivers improvement within 48 hours

The principal factor differentiating Nemluvio from existing treatments is its mechanism of action. Although several biologics target itching, Nemluvio is the only one that targets IL-31, a key cytokine that directly transmits itch signals. This distinguishes it from existing biologics that inhibit the IL-4 or IL-13 pathways involved in immune and inflammatory responses. Nemluvio is designed to interrupt at its source the itch–scratch cycle that causes the greatest distress to patients with atopic dermatitis and prurigo nodularis.

The clinical benefits of targeting IL-31 were demonstrated in the large-scale global Phase III ARCADIA 1 and 2 trials in atopic dermatitis and the OLYMPIA 1 and 2 trials in prurigo nodularis.

In atopic dermatitis, 44% of patients treated with Nemluvio achieved at least a 75% improvement in skin lesions at Week 16, as measured by EASI-75, compared with 29% in the placebo group. Itching was significantly reduced versus placebo beginning 48 hours after administration. In prurigo nodularis, 38% of patients receiving Nemluvio achieved clear or almost clear skin, defined as IGA 0 or 1, at Week 16, more than three times the 11% rate in the placebo group. In both indications, the drug demonstrated a significant reduction in itching compared with placebo within just 48 hours of administration.

Nemluvio prefilled pen

Annual injections reduced by 81%...2-year long-term safety demonstrated, ‘strongly recommended’ in guidelines

Nemluvio is also considered competitive in terms of treatment convenience as well. For atopic dermatitis, it is initially administered once every 4 weeks. Patients who demonstrate a clinical response at Week 16 can subsequently transition to maintenance treatment once every 8 weeks.

By reducing the annual number of injections to approximately 10, Nemluvio has been credited with decreasing the burden of treatment and hospital visits by approximately 81% compared with therapies administered every 2 weeks (26 times per year).

Its efficacy was sustained in long-term extension studies lasting approximately 2 years. Among patients with atopic dermatitis, more than 85% achieved EASI-75, and more than 58% achieved IGA 0 or 1 at Week 104.

Based on SCORAD visual analog scale (VAS) scores that measure itch severity, approximately 85% of patients achieved an improvement of at least 4 points at Week 104, while around 70% reached a level at which itching was absent or nearly absent.

Among patients with prurigo nodularis, 73% achieved IGA 0 or 1 at Week 100, while more than 70% achieved absent or almost absent itch ((PP-NRS<2). Also, no new safety signals were observed, suggesting that Nemluvio could serve as a new treatment option offering sustained efficacy and a consistent safety profile in both diseases that inevitably require long-term treatment.

Based on its rapid efficacy and convenience in administration, the American Academy of Dermatology (AAD) recommended Nemluvio in its updated 2025 atopic dermatitis treatment guidelines for use in combination with topical therapies in adults with moderate to severe disease.

Korean launch draws near…with reimbursement targeted for first half of next year

Galderma Korea is also accelerating Nemluvio’s entry into the Korean market. In January this year, the drug received approval from the MFDS for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and older, and for prurigo nodularis in adults, when topical prescription therapies do not provide adequate control or are not recommended.

The drug is currently undergoing the reimbursement listing process, with the company seeking a reimbursed launch for atopic dermatitis in the first half of 2027.

Nemluvio is the only biologic approved in Korea that targets the IL-31 receptor. Its introduction is expected to broaden the focus of atopic dermatitis treatment in Korea, which was previously centered on improving skin lesions and controlling inflammation, to include rapid itch relief and improved quality of life through once-every-8-week dosing.