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# FDA OKs Galderma Dermatitis Drug Nemluvio
- URL: https://www.fdaweb.com/fda-oks-galderma-dermatitis-drug-nemluvio/
- Published: 2025-01-06T12:00:00.000Z
- Updated: 2026-09-14T14:50:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158381

FDA has approved Galderma’s Nemluvio (nemolizumab) for a new indication to treat patients aged 12 and older with moderate to severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. In 8/2024, the agency approved Nemluvio for subcutaneous injection to treat adults with prurigo nodularis.

Galderma [says](https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-congenital-adrenal-hyperplasia?ref=fdaweb.com) approval for the new indication was based on positive results from the Phase 3 ARCADIA trial.

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