On 18 February 2025, Galderma announced that Nemluvio® (nemolizumab) for subcutaneous administration has been approved in the UK and Switzerland for two indications:
- moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors in adults and adolescents 12 years of age and older with a body weight of at least 30kg, who are candidates for systemic therapy; and
- moderate-to-severe prurigo nodularis in adults who are candidates for systemic therapy.
According to Galderma, these are the first approvals from countries within the Access Consortium framework, an international collaborative initiative comprised of regulatory authorities which work together to address shared challenges. Nemluvio® is currently under review in Australia and Singapore, the remaining members of the Access Consortium, with decisions expected later this year.
Just four days earlier, Galderma announced the approval of Nemluvio® in the EU for the same indications. Nemluvio® has also been approved in the US for moderate to severe atopic dermatitis (December 2024) and prurigo nodularis (August 2024).