Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration (FDA) has updated the label for Dupixent® (dupilumab) in atopic dermatitis, adding efficacy and safety data for patients aged 12 years and older with atopic dermatitis with uncontrolled moderate-to-severe hand and/or foot involvement. These Phase 3 data are from the first and only trial evaluating a biologic specifically for this difficult-to-treat population and have also been added to the Dupixent label in the European Union, with regulatory submissions underway in additional countries. The label update is based on data from the Phase 3 LIBERTY-AD-HAFT trial.

In the trial, patients received Dupixent (n=67) every two weeks (adults 300 mg, adolescents 200 mg or 300 mg based on body weight) or placebo (n=66). At 16 weeks, patients treated with Dupixent experienced the following: 40% achieved clear or almost clear skin on hands and feet compared to 17% with placebo, the primary endpoint, 52% saw a clinically meaningful reduction in itch on hands and feet compared to 14% with placebo, the key secondary endpoint. The safety results were generally consistent with the known safety profile of Dupixent in atopic dermatitis.

Most common adverse events (AEs) observed with Dupixent (=1%) in atopic dermatitis include injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye and eosinophilia. The Phase 3 double-blind, placebo-controlled trial, LIBERTY-AD-HAFT, evaluated the efficacy and safety of Dupixent in 133 adult and adolescent (aged 12 to 17 years) patients with atopic dermatitis with moderate-to-severe hand and/or foot involvement who had an inadequate response or intolerance to topical corticosteroids. Patients with hand and foot disease predominantly driven by allergic or irritant contact dermatitis were excluded from the trial.

The primary endpoint evaluated the proportion of patients with clear or almost clear skin of hand and feet eczema at 16 weeks, as measured by a score of 0 or 1 on the Investigator Global Assessment Scale. The key secondary endpoint measured the proportion of patients with improvement in itch on hands and feet from baseline (measured by a =4-point reduction in Peak-Pruritis Numeric Rating Scale [PP-NRS] on a 0-10 scale) at 16 weeks. Dupixent, which was invented using Regeneron's proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant.

The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE) and prurigo nodularis. Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in different age populations.

Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. More than 800,000 patients are being treated with Dupixent globally.