FDA Approves Nemluvio for Moderate-to-Severe Atopic Dermatitis

ZUG, Switzerland – On December 13, 2024, Galderma (SWX:GALD) announced the United States Food and Drug Administration (FDA) approval of Nemluvio (nemolizumab) for treating patients aged 12 and older with moderate-to-severe atopic dermatitis. This approval marks a significant step forward in providing relief to individuals whose conditions are not adequately managed by topical prescription therapies. The treatment can be used in conjunction with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI).

Atopic dermatitis is a chronic inflammatory skin condition affecting over 230 million individuals globally, including around 7% of the U.S. population. Patients frequently report itching as one of the most distressing symptoms, with a substantial 87% prioritizing rapid itch relief. The disease is characterized by its heterogeneity and is often associated with comorbid conditions such as mental health disorders and other autoimmune diseases. Despite the availability of treatments, many patients do not achieve optimal results, underscoring the necessity for innovative therapeutic options.

Nemluvio distinguishes itself as the first approved monoclonal antibody that targets the IL-31 receptor alpha, a critical mediator in the neuroimmune pathway responsible for itch and inflammation in atopic dermatitis. The approval is supported by the successful outcomes of the phase III ARCADIA clinical trial program. This program assessed the efficacy and safety of Nemluvio in combination with TCS, with or without TCI, compared to a placebo, in 1,728 patients aged 12 years and older with moderate-to-severe atopic dermatitis.

The clinical trials demonstrated that patients receiving subcutaneous Nemluvio injections every four weeks, alongside TCS with or without TCI, showed significant improvements in skin clearance. The co-primary endpoints included achieving clearance or near-clearance of skin lesions based on the investigator’s global assessment score and a 75% reduction in the Eczema Area and Severity Index (EASI) compared to the placebo group after 16 weeks of treatment. Furthermore, Nemluvio provided significant itch relief from as early as one week into the treatment and improved sleep disturbances when compared to the placebo.

Safety analysis from the trials indicated that Nemluvio was generally well tolerated, with a safety profile consistent between the treatment and placebo groups. Additionally, in August 2024, the FDA approved Nemluvio as a pre-filled pen for the subcutaneous treatment of adults with prurigo nodularis.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has also given a positive opinion on December 12, 2024, recommending Nemluvio’s approval in the European Union for treating atopic dermatitis and prurigo nodularis. The European Commission is now tasked with the final approval across the EU member states and additional territories like Iceland, Liechtenstein, and Norway.

Galderma is actively pursuing marketing authorizations for Nemluvio in several other countries, including Australia, Singapore, and Switzerland, through the Access Consortium framework. Further submissions are planned for other global regulatory authorities in 2025. The company anticipates Nemluvio to achieve blockbuster status, with peak sales expected to surpass 2 billion USD by the end of 2027.

Nemluvio was initially developed by Chugai Pharmaceutical Co., Ltd., with Galderma obtaining worldwide development and marketing rights in 2016, excluding Japan and Taiwan. In Japan, marketed as Mitchga, it is approved for treating prurigo nodularis and itch associated with atopic dermatitis.

Atopic dermatitis remains the most prevalent inflammatory skin disease worldwide, affecting more individuals than psoriasis. Although current treatments provide relief, many patients do not experience complete itch relief or skin clearance, highlighting the ongoing need for advanced therapeutic solutions.