FDA

Nemluvio now approved for atopic dermatitis

December 19, 2024

Brand name: Nemluvio

Generic name: nemolizumab-ilto

Manufacturer: Galderma

Approval date: December 14, 2024

FDA approved Nemluvio (nemolizumab), an IL-31 receptor antagonist, for the treatment of patients ≥12 years of age with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when the disease isn’t adequately controlled with topical prescription therapies.

According to a manufacturer press release, Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting signaling of IL-31, a neuroimmune cytokine that drives itch and is involved in inflammation and epidermal dysregulation in atopic dermatitis.

In August 2024, Nemluvio was approved for the treatment of adults with prurigo nodularis.

Efficacy

Approval was based on data from two phase 3 randomized trials, ARCADIA 1 (NCT03985943) and ARCADIA 2 (NCT03989349) that evaluated the efficacy and safety of Nemluvio in combination with background TCS, with or without TCI, vs. placebo in combination with TCS, with or without TCI, in 1,728 patients ages ≥12 years of age with moderate-to-severe atopic dermatitis.

Results showed that patients treated with Nemluvio, administered SC q4wks in combination with TCS, with or without TCI, showed statistically significant improvements on skin clearance in both co-primary endpoints, which were as follows:

• Proportion of participants with Investigator’s Global Assessment (IGA) success, defined as an IGA of 0 (clear) or 1 (almost clear) at week 16
• Proportion of participants achieving a 75% reduction in the Eczema Area and Severity Index (EASI) at week 16

The trials also met all key secondary endpoints confirming significant responses on itch as early as week 1, and statistically significant improvements in sleep disturbance.

Safety

The most common adverse reactions (incidence ≥1%) among Nemluvio-treated patients were headache (including migraine), arthralgia, urticaria, and myalgia.

Recommended dose

The recommended initial dosage of Nemluvio is 60 mg (two 30-mg SC injections), followed by 30 mg SC q4wks. After 16 weeks of treatment, for patients who achieve clear or almost clear skin, a dosage of 30 mg SC q8wks is recommended. Nemluvio should be used with TCS and/or TCI. When the disease has sufficiently improved, topical therapies may be discontinued.

Sources:

Galderma. (2024, December 14). Galderma Receives U.S. FDA Approval for Nemluvio (Nemolizumab) for Patients with Moderate-to-Severe Atopic Dermatitis. [Press release]. https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-patients-moderate-severe-atopic

Galderma: Nemluvio (nemolizumab-ipdl). [Package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761391s000lbl.pdf