Media Update: Dupixent® (dupilumab) U.S. label updated with data further supporting use in atopic dermatitis with moderate-to-severe hand and foot involvement
Dupixent® (dupilumab) U.S. label updated with data further supporting use in atopic dermatitis with moderate-to-severe hand and foot involvement
- Data included from first and only Phase 3 trial specifically evaluating a biologic in this difficult-to-treat population
- Phase 3 trial showed more than twice as many patients treated with Dupixent achieved clear or almost clear skin and nearly four times as many had improvement in itch, compared with placebo
PARIS and TARRYTOWN, N.Y., January 16, 2024. 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.
Naimish Patel, M.D.
Head of Global Development, Immunology and Inflammation, Sanofi
“Living with atopic dermatitis on your most essential body areas like the hands and feet can make daily activities including walking and writing incredibly burdensome even in the case where disease symptoms are mild elsewhere. Unfortunately, treating atopic dermatitis on the hands and feet has historically been difficult and there have been no Phase 3 trials evaluating a biologic in this population of patients. Having these data added for this difficult-to-treat population is important for physicians looking for tools to treat these patients and reinforces the already well-established efficacy and safety of Dupixent in atopic dermatitis overall.”
George D. Yancopoulos, M.D., Ph.D.
Board co-Chair, President and Chief Scientific Officer, Regeneron
“We rely heavily on our hands and feet throughout the day, making atopic dermatitis particularly disruptive for patients who experience constant itch and painful cracking and bleeding skin lesions on these critical areas of the body. Dupixent has been used to treat hundreds of thousands of patients with moderate-to-severe atopic dermatitis around the world since its initial U.S. approval in 2017, and we are pleased that Dupixent is now the first biologic with data in the label supporting its use in this particularly challenging subset of the disease.”
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
Results from this Phase 3 trial were most recently accepted in the Journal of the American Academy of Dermatology.
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.
About the Clinical Trial
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 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.
Dupilumab Development Program
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.
In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric EoE, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.
Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led for over 35 years by physician-scientists, Regeneron’s unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in Regeneron’s laboratories. Regeneron’s medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through its proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center®, which is conducting one of the largest genetics sequencing efforts in the world.
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
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