FDA Approves Nemluvio for Atopic Dermatitis Treatment

The US Food and Drug Administration (FDA) recently granted approval for Galderma’s monoclonal antibody treatment, Nemluvio (nemolizumab), designed for individuals aged 12 and older suffering from moderate-to-severe atopic dermatitis. This new therapeutic option is intended to be used alongside topical corticosteroids and/or calcineurin inhibitors when existing topical prescription medications fail to adequately manage the condition.

The FDA’s approval decision was heavily influenced by the promising results of the ARCADIA Phase III clinical trial. This extensive research involved 1,728 participants aged 12 and above, all dealing with moderate-to-severe atopic dermatitis. The trial demonstrated that the combination therapy of Nemluvio significantly outperformed placebo treatments in terms of skin clearance.

Flemming Ørnskov, CEO of Galderma, remarked on this development by highlighting Nemluvio as a testament to their innovative, science-driven projects. He emphasized the treatment's significance as an effective new option for patients with atopic dermatitis, addressing unmet medical needs. Ørnskov further noted that this FDA approval marks an important milestone in the expansion of Galderma's therapeutic dermatology portfolio in the US, reinforcing their commitment to pioneering first-in-class dermatological solutions.

The recent approval is part of a broader context, following the FDA’s previous endorsement of Nemluvio for subcutaneous injection to treat adults with prurigo nodularis in August 2024. This reflects the growing recognition of Nemluvio's potential in tackling challenging dermatological conditions.

In Europe, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has similarly issued a positive opinion on the therapy, recommending its approval for both atopic dermatitis and prurigo nodularis. The European Commission is expected to review this recommendation to determine the therapy’s potential approval across the European Union and additional countries.

Galderma is actively pursuing marketing authorization for Nemluvio in several regions worldwide. Regulatory applications are currently under review in countries such as Australia, Brazil, Canada, Singapore, South Korea, and Switzerland, through the access consortium framework. Further submissions are anticipated for 2025, reflecting Galderma's strategic efforts to broaden the availability of this treatment.

Nemluvio was initially developed by Chugai Pharmaceutical, with Galderma acquiring its development and marketing rights in 2016, with the exception of Japan and Taiwan. In Japan, the treatment is marketed as Mitchga and has received approval for prurigo nodularis and associated pruritus.

This recent FDA approval of Nemluvio underscores Galderma’s dedication to expanding its dermatological offerings and addressing the diverse needs of patients worldwide. With Nemluvio, Galderma is poised to enhance its impact in the global dermatology market, providing innovative solutions for conditions that have long posed challenges in effective management.