NEMLUVIO

What it is

Nemluvio is nemolizumab 30 mg powder and solvent for solution for injection in a pre-filled pen. Nemolizumab is a humanised monoclonal antibody of the IgG2 subclass that inhibits IL-31 signalling by binding selectively to IL-31RA. IL-31 is a neuroimmune cytokine that drives pruritus and inflammation, which are important pathophysiological components of atopic dermatitis and prurigo nodularis.

Approved indications

— Moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or topical calcineurin inhibitors in adults and patients aged 12 years and above who weigh at least 30 kg, who are candidates for systemic therapy. — Moderate-to-severe prurigo nodularis in adults who are candidates for systemic therapy.

Dosing overview

Nemluvio is administered as a subcutaneous injection into the front upper thighs or abdomen, avoiding the 5 centimetre area around the navel.

Key safety warnings

Cases of hypersensitivity reactions, including urticaria and angioedema, have been reported with use of Nemluvio. If a systemic hypersensitivity reaction occurs, administration of Nemluvio should be discontinued and appropriate therapy initiated. All age-appropriate vaccinations as recommended by current immunisation guidelines should be completed prior to initiating treatment with Nemluvio. Live vaccines should be avoided in patients treated with Nemluvio. Patients with uncontrolled asthma were excluded from the trials and no data with Nemluvio are available in this population. Upon initiation of therapy with Nemluvio, do not discontinue corticosteroids abruptly. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Regulatory history

Nemluvio received initial ARTG registration on 27 May 2025. This medicinal product is subject to additional monitoring in Australia, which will allow quick identification of new safety information. In July 2025, the PBAC did not recommend Nemluvio for severe atopic dermatitis affecting the whole body, face, and/or hands, finding it was not adequately supported as similarly effective to dupilumab.