Nemluvio FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 17, 2024.
FDA Approved: Yes (First approved August 12, 2024)
Brand name: Nemluvio
Generic name: nemolizumab
Dosage form: for Injection
Company: Galderma Laboratories, L.P.
Treatment for: Prurigo Nodularis, Atopic Dermatitis
Nemluvio (nemolizumab) is an interleukin-31 receptor antagonist indicated for the treatment of prurigo nodularis and atopic dermatitis.
- Nemluvio is indicated for the treatment of:
- adults with prurigo nodularis.
- adults and pediatric patients 12 years of age 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. - Prurigo nodularis is a rare, neuroimmune skin disease characterized by thick skin nodules with intense itching. Atopic dermatitis is a common, inflammatory skin disease characterized by persistent itch and recurrent skin lesions.
- Nemluvio contains nemolizumab, a monoclonal antibody that specifically inhibits IL-31 cytokine signaling. IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and epidermal dysregulation in both prurigo nodularis and atopic dermatitis.
- FDA approval of Nemluvio for the treatment of prurigo nodularis was based on results from the phase III OLYMPIA 1 and OLYMPIA 2 clinical trials which demonstrated that:
- 56% of Nemluvio-treated patients in OLYMPIA 1 and 49% in OLYMPIA 2 achieved at least a four-point reduction in itch intensity at Week 16 compared to 16% in both placebo groups;
- 26% of Nemluvio-treated patients in OLYMPIA 1 and 38% OLYMPIA 2 reached clearance of skin nodules at Week 16 compared to 7% and 11% in the placebo groups; and
- 50% of Nemluvio-treated patients in OLYMPIA 1 and 52% in OLYMPIA 2 achieved at least a four-point reduction in sleep disturbance at Week 16 compared to 12% and 21% in the placebo groups. - FDA approval of Nemluvio for the treatment of atopic dermatitis was based on results from the phase III ARCADIA clinical trial program which demonstrated statistically significant improvements on skin clearance in both co-primary endpoints (clearance or almost-clearance of skin lesions when assessed using the investigator’s global assessment score, and achieving a 75% reduction in the Eczema Area and Severity Index) when compared to placebo in combination with topical corticosteroids and/or calcineurin inhibitors after 16 weeks of treatment.
- Nemluvio is administered by subcutaneous injection every 4 weeks. Nemluvio is supplied as a single-dose prefilled dual-chamber pen containing lyophilized powder and diluent for reconstitution prior to administration.
- Warnings and precautions associated with Nemluvio include hypersensitivity reactions.
- Common adverse reactions (incidence ≥1%) in prurigo nodularis patients include headache, atopic dermatitis, eczema, and nummular eczema.
Common adverse reactions (incidence ≥1%) in atopic dermatitis patients include headache (including migraine), arthralgia, urticaria, and myalgia.
Development timeline for Nemluvio
Further information
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