The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Galderma’s Nemluvio (nemolizumab) to treat both atopic dermatitis and prurigo nodularis.

The UK regulator has specifically approved the drug to treat atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors in adults and adolescents aged 12 years and older with a body weight of at least 30kg and for adults with prurigo nodularis.

Eligible patients must also have moderate-to-severe cases of the skin diseases and be candidates for systemic therapy.

Atopic dermatitis, characterised by persistent itch and recurrent skin lesions, affects up to 1.6 million people in the UK, while prurigo nodularis, which causes intense itch and thick skin nodules, affects approximately 18,000 people in the UK.

Nemluvio, which was initially developed by Chugai Pharmaceutical and administered as a subcutaneous injection every four weeks, is designed to inhibit signalling of the neuroimmune cytokine interleukin-31, which drives itch and is involved in inflammation and skin barrier dysfunction.

The MHRA’s decision comes shortly after the European Commission authorised Nemluvio for both conditions and makes the drug the first approved monoclonal antibody in the UK that specifically targets interleukin-31 receptor alpha.

The approval in atopic dermatitis was based on results from the late-stage ARCADIA 1 and 2 studies, in which Nemluvio in combination with background topical corticosteroids (TCS) was associated with statistically significant improvements in the co-primary and key secondary endpoints compared to placebo plus TCS after 16 weeks of treatment, with significant itch relief observed from as early as week one.

The authorisation in prurigo nodularis was supported by data from the phase 3 OLYMPIA 1 and 2 trials, which met both primary and key secondary endpoints, demonstrating that treatment with Nemluvio resulted in significant and clinically meaningful improvements in itch and skin nodules at week 16, with reductions in itch observed from week four.