Watch as Dr James Del Rosso provides an in-depth overview of Nemluvio (nemolizumab) for atopic dermatitis, including clinical trial results, dosing, safety, and more. 

Galderma has announced that the US Food and Drug Administration (FDA) has approved Nemluvio (nemolizumab) for the treatment of moderate-to-severe atopic dermatitis in patients 12 years and older. This approval allows the use of Nemluvio in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) for cases where topical prescription therapies alone do not provide adequate disease control. 

Innovative mechanism of action 

Nemluvio is the first monoclonal antibody approved to specifically target the IL-31 receptor alpha, inhibiting the signaling of IL-31, a neuroimmune cytokine linked to itch, inflammation, and epidermal dysregulation in atopic dermatitis. 

Clinical trial insights 

The FDA approval is based on positive findings from the Phase III ARCADIA clinical trial program, which assessed the efficacy and safety of Nemluvio in combination with TCS, with or without TCI, compared to placebo in 1728 patients aged 12 years or older with moderate-to-severe atopic dermatitis. 

Key findings from the study include: 

• Improved skin clearance: Patients treated with Nemluvio, in combination with TCS, with or without TCI, achieved statistically significant improvements in both coprimary endpoints: 
  • Investigator’s Global Assessment (IGA) scores of “clear” (0) or “almost clear” (1) of skin lesions 
  • At least a 75% reduction in the Eczema Area and Severity Index (EASI-75) compared to placebo, in combination with TCS, with or without TCI, after 16 weeks of treatment 
• Rapid itch relief: Significant responses in itch reduction were observed as early as Week 1, along with improvements in sleep disturbance, when compared to placebo 

Safety profile 

Nemluvio demonstrated a favorable safety profile, with tolerability comparable to placebo. The most common adverse reactions (≥1%) in patients treated with Nemluvio included headache (including migraine), arthalgia, urticaria, and myalgia. 

Expanding therapeutic options 

This approval builds on Nemluvio’s earlier FDA approval in August 2024 for the treatment of prurigo nodularis in adults, highlighting its versatility in managing conditions associated with IL-31 dysregulation.