MHRA Approves Nemluvio for Atopic Dermatitis and Prurigo Nodularis

The Medicines and Healthcare products Regulatory Agency (MHRA) has recently granted approval for Galderma’s medication, Nemluvio (nemolizumab), to be used in treating both atopic dermatitis and prurigo nodularis. This regulatory approval is significant as it paves the way for new therapeutic options in the UK for managing these chronic skin conditions.

Nemluvio is now approved for use in individuals aged 12 years and older who suffer from atopic dermatitis. The treatment can be administered alongside topical corticosteroids and/or calcineurin inhibitors, particularly in patients whose body weight is at least 30 kilograms. The approval also extends to adults with prurigo nodularis. Importantly, candidates for this treatment must present with moderate-to-severe forms of these skin diseases and should be suitable for systemic therapy.

Atopic dermatitis, a condition known for its persistent itching and recurrent skin lesions, impacts approximately 1.6 million individuals in the UK. On the other hand, prurigo nodularis, which results in intense itching and the development of thick skin nodules, affects around 18,000 people in the UK. Despite the availability of various treatments, there remains a significant need for new therapeutic interventions that can effectively alleviate the symptoms of these conditions.

Developed initially by Chugai Pharmaceutical, Nemluvio is administered via subcutaneous injection every four weeks. The drug functions by inhibiting the signaling of the neuroimmune cytokine interleukin-31. This cytokine is a key driver of itching and is involved in the processes of inflammation and skin barrier dysfunction. With the MHRA’s approval, Nemluvio becomes the first monoclonal antibody approved in the UK that specifically targets the interleukin-31 receptor alpha.

The decision by the MHRA follows closely on the heels of the European Commission’s authorization of Nemluvio for treating both atopic dermatitis and prurigo nodularis. The approval for treating atopic dermatitis was based on compelling results from the ARCADIA 1 and 2 studies. In these late-stage clinical trials, Nemluvio, when used alongside topical corticosteroids, demonstrated significant improvements in primary and secondary endpoints compared to placebo, showing marked relief from itching as early as one week into the treatment.

Similarly, Nemluvio’s approval for prurigo nodularis was underpinned by data from the phase 3 OLYMPIA 1 and 2 trials. These trials met both primary and important secondary endpoints, proving that the treatment led to substantial and clinically meaningful improvements in itching and skin nodules by week 16, with noticeable reductions in itch starting from the fourth week.

Baldo Scassellati Sforzolini, who serves as the global head of research and development at Galderma, expressed optimism about Nemluvio’s approval in the UK. He highlighted that the decision was backed by robust data from the ARCADIA and OLYMPIA clinical trials, underscoring Nemluvio’s potential to alleviate some of the most challenging symptoms associated with moderate-to-severe atopic dermatitis and prurigo nodularis.

This approval marks a significant advancement in the treatment landscape for these chronic skin conditions, offering new hope for patients seeking relief from their symptoms.