The recommended dosage of nemolizumab is 30 mg, administered via injection using a pre-filled pen or syringe, and is intended to be used alongside topical treatments when necessary.

For atopic dermatitis, the drug's efficacy was demonstrated in two double-blind phase 3 trials with 1,728 participants, where around 40% showed significant improvement in their skin condition.

Nemolizumab is indicated for individuals aged 18 and older with prurigo nodularis and for those aged 12 and older with atopic dermatitis, provided they weigh at least 30 kg.

In the ARCADIA trials, nemolizumab demonstrated statistically significant improvements in skin clearance at week 16 compared to placebo, with higher rates of Investigator’s Global Assessment success.

The approval for prurigo nodularis was based on two phase 3 clinical trials involving 560 adults, where about 60% experienced significant itch reduction and 30% achieved clear or almost clear skin.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved nemolizumab (Nemluvio) for treating moderate to severe prurigo nodularis in adults and atopic dermatitis in adolescents and adults.

Interim data from the OLYMPIA long-term extension study indicated that over 60% of patients treated with nemolizumab achieved clear or almost-clear skin after one year.

This approval follows the European Commission's decision on February 14, 2025, which also endorsed nemolizumab for these conditions.

As a humanized IgG2 monoclonal antibody, nemolizumab specifically targets interleukin-31, a protein linked to itch, inflammation, and skin barrier dysfunction.

The MHRA will continue to monitor the safety and effectiveness of nemolizumab, encouraging reporting of side effects through the Yellow Card scheme.

Common side effects include hypersensitivity and injection site reactions, with a similar percentage of patients experiencing treatment-emergent adverse events across trials.

The National Institute for Health and Care Excellence is currently evaluating nemolizumab for NHS use in England, with guidance expected by May 2025.