Nemluvio FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 13, 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
Nemluvio (nemolizumab) is an interleukin-31 receptor antagonist indicated for the treatment of adults with prurigo nodularis.
- Prurigo nodularis is a rare, neuroimmune skin disease characterized by thick skin nodules with intense itching.
- Nemluvio contains nemolizumab, a monoclonal antibody that specifically inhibits IL-31 cytokine signaling. IL-31 is a neuroimmune cytokine that drives multiple disease mechanisms in prurigo nodularis including itch, inflammation, altered epidermal differentiation, and fibrosis (hardening of skin tissue).
- FDA approval of Nemluvio is 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. - Nemluvio is administered by subcutaneous injection every 4 weeks. Nemluvio is supplied in a single-dose prefilled dual-chamber pen with white powder in one chamber and a clear diluent in the other chamber, and must be reconstituted prior to administration.
- Warnings and precautions associated with Nemluvio include hypersensitivity reactions.
- Common adverse reactions (incidence ≥1%) include headache, dermatitis atopic, eczema, and eczema nummular.
- The FDA has also accepted for review the Biologics License Application for Nemluvio for the treatment of moderate-to-severe atopic dermatitis, with a decision anticipated later in 2024.
Development timeline for Nemluvio
Further information
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