Dermatology specialist Galderma (SWX:GALD) announced on Tuesday that Nemluvio (nemolizumab) has been granted marketing authorisation by the United Kingdom's Medicines and Healthcare products Regulatory Agency and Switzerland's Swissmedic for moderate-to-severe atopic dermatitis and prurigo nodularis.

This marks the first approvals within the Access Consortium framework, with additional reviews pending in Australia and Singapore.

Nemolizumab is the first monoclonal antibody to target IL-31 receptor alpha, a neuroimmune cytokine responsible for itch and inflammation in both conditions. The subcutaneous treatment is approved for adults and adolescents 12 years and older who are candidates for systemic therapy.

The approvals are supported by data from the phase III ARCADIA and OLYMPIA trials, which showed improvements in skin lesions, itch and sleep quality. The safety profile was consistent with prior studies.

Nemolizumab is also approved in the European Union and the United States for the same indications. Atopic dermatitis and prurigo nodularis affect a significant number of people, with a high need for effective treatments to address chronic itch and related symptoms.