Tarrytown, New York and Paris, December 13, 2021 /PRNewswire/-
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced detailed Phase 3 positive results, demonstrating that the addition of Dupixent® (dupilumab) to standard care topical corticosteroids (TCS) can be significant To improve skin clearance and reduce overall disease severity and itching in infants and children 6 months to 5 years old with uncontrolled moderate to severe atopic dermatitis. These data will be announced today at the latest meeting of the 2021 Revolutionary Atopic Dermatitis Conference (RAD 2021).
"As a doctor, one of the most challenging aspects of my job is to help infants and young children with moderate to severe atopic dermatitis. The treatment options are limited, which may undermine their ability to fully thrive early in life. ," said Amy S. Paller, MD, Professor Walter J. Hamlin, Chair of Dermatology and Professor of Pediatrics at Northwestern University’s Feinberg School of Medicine, and the lead investigator of the trial. "These results show that dupilumab can significantly improve the signs and overall severity of atopic dermatitis in 6-month-old children. When treating such a young child, safety is of paramount importance. We are very pleased that these data show that the safety and the overall severity of atopic dermatitis What we have seen in other age groups. We will continue to follow these patients for up to 5 years in an open-label trial."
85% to 90% of people with atopic dermatitis develop symptoms before the age of 5, and they usually persist into adulthood. Symptoms include intense, persistent itching and skin lesions covering most of the body (an average of 58% of patients in the trial at baseline), causing dryness, cracking, redness or blackening, crusting and exudation of the skin, and risks Increase skin infections. Moderate to severe atopic dermatitis can also significantly affect the quality of life of young children, their parents and caregivers. In addition, the underlying type 2 inflammation involved in atopic dermatitis can lead to the development of other diseases, such as asthma and certain allergies, and these diseases may also run through a person's life.
The top-line results of a randomized, placebo-controlled pivotal trial that meets all primary and secondary endpoints will be announced in August 2021. Data provided on RAD 2021 showed that at 16 weeks, patients who added Dupixent to low-efficiency TCS (placebo) experienced the following:
The safety profile observed in randomized, placebo-controlled trials is consistent with Dupixent's recognized safety profile in adults, adolescents, and children 6 years of age and older with moderate to severe atopic dermatitis. Dupixent's overall adverse event (AE) rate was 64% and placebo was 74%. The most common AEs and AEs of particular interest include nasopharyngitis (8% Dupixent, 9% placebo), upper respiratory tract infection (6% Dupixent, 8% placebo), and conjunctivitis (5% Dupixent, 0% placebo) And herpes virus infection (6% Dupixent, 5% placebo).
These results will form the basis for global regulatory submissions for this age group, starting from the United States in 2021 and the European Union in the first half of 2022.
In addition, long-term data from a phase 3 trial in patients with moderate to severe atopic dermatitis between the ages of 6 and 11 were also announced at the recent conference. The one-year efficacy and safety results are consistent with the known characteristics of Dupixent in atopic dermatitis.
The data from these trials adds to the extensive LIBERTY AD clinical program—the largest phase 3 clinical trial program for atopic dermatitis to date, involving approximately 3,500 infants, children, adolescents, and adults.
Dupixent is the first biologic drug to show positive results in this young patient population. The effectiveness and safety of Dupixent in children under 6 years of age has not been fully evaluated by any regulatory agency.
About the Dupixent trial LIBERTY AD PRESCHOOL is a two-part phase 2/3 trial. The randomized, double-blind, placebo-controlled portion of the trial (Part B) of the trial evaluated the efficacy and safety of Dupixent added to the standard care ineffective TCS compared with the ineffective TCS alone (placebo). 162 patients Children 6 months to 5 years of age with uncontrolled moderate to severe atopic dermatitis.
The primary endpoint evaluated the proportion of patients with a 75% improvement in the Investigator's Overall Assessment (IGA) score and the Eczema Area and Severity Index (EASI-75) who achieved 0 (cleared) or 1 (almost cleared) at week 16. EASI measures the degree and severity of the disease. Use the 0 to 10 numeric rating scale reported by the caregiver to assess itching. Patients receiving Dupixent receive 200 mg (for children weighing ≥5 to <15 kg) or 300 mg (for children weighing ≥15 to <30 kg) every 4 weeks.
There were 162 patients in the trial (83 Dupixent, 79 placebo), with an average age of 3.8 years, and 61% were men. Approximately 12% of patients are Latino/Hispanic, and 19% are black/African American. At the beginning of the trial, 77% of patients had serious illnesses, and 29% of patients had previously used systemic immunosuppressants to treat atopic dermatitis. On average, patients’ atopic dermatitis covered 58% of the body. In addition, 81% of these patients have at least one type 2 inflammation and/or allergic disease at the same time, such as allergic rhinitis and asthma.
Part B of the Phase 3 trial is informed by Part A. This is an open-label, single-dose escalation, sequential cohort Phase 2 trial designed to evaluate Dupixent's pharmacokinetics in uncontrolled children between 6 months and 5 years of age Severe atopic dermatitis.
Children who complete part A or part B of the trial are eligible to participate in an open-label extension trial to evaluate the safety and effectiveness of Dupixent for an additional five years of long-term treatment in this age group.
About Dupixent Dupixent was invented using Regeneron’s proprietary VelocImmune® technology. It is a fully human monoclonal antibody that inhibits the signal transduction of interleukin 4 (IL-4) and interleukin 13 (IL-13) pathways. Dupixent is not an immunosuppressant and does not require laboratory monitoring. IL-4 and IL-13 are the key and central drivers of type 2 inflammation, and play a major role in atopic dermatitis, asthma, and chronic sinusitis with nasal polyposis (CRSwNP).
Dupixent is currently approved for use in certain moderate to severe atopic dermatitis patients in the United States, Europe, Japan and other countries in the world, as well as patients with asthma or CRSwNP in certain people of different ages. Dupixent has also been approved for one or more of these indications in more than 60 countries around the world, and more than 300,000 patients have been treated worldwide.
About Regeneron's VelocImmune technology Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform that has a genetically humanized immune system that can produce optimized fully human antibodies. When George D. Yancopoulos, President and Chief Scientific Officer of Regeneron, was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision the creation of such genetically humanized mice, and Regeneron took dozens of them. Years invented and developed VelocImmune and related VelociSuite ® technology. Dr. Yancopoulos and his team have used VelocImmune technology to manufacture approximately a quarter of all the original, FDA-approved or authorized fully human monoclonal antibodies currently available. This includes Dupixent, REGEN-COV® (casirivimab and imdevimab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnimab) and Inmazeodeb™ (atoltivimab), and maft -ebgn).
Dupilumab development plan Dupilumab was jointly developed by Regeneron and Sanofi in accordance with a global cooperation agreement. To date, dupilumab has been studied in 60 clinical trials involving more than 10,000 patients with various chronic diseases, which are partly driven by type 2 inflammation.
In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab to treat a wide range of diseases caused by type 2 inflammation or other allergic processes, including atopic dermatitis in children (6 months to 5 years, phase 3), Chronic obstructive pulmonary disease diseases with evidence of type 2 inflammation (stage 3), eosinophilic esophagitis (stage 3), bullous pemphigoid (stage 3), prurigo nodularis (stage 3) Stage), chronic spontaneous urticaria (stage 3), chronic induced urticaria-cold (stage 3), chronic sinusitis without nasal polyposis (stage 3), allergic fungal rhinosinusitis (stage 3) Stage 3), allergic bronchopulmonary aspergillosis (stage 3) and peanut allergy (stage 2). These potential uses of dupilumab are currently under clinical research, and the safety and effectiveness in these cases have not been fully evaluated by any regulatory agency.
DUPIXENT is a prescription medicine used to:
Important safety information for American patients
Do not use if you are allergic to dupilumab or any of the ingredients in DUPIXENT®.
Before using DUPIXENT, please tell your healthcare provider about all your health conditions, including whether you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
If you are taking oral, topical, or inhaled corticosteroids, especially tell your healthcare provider; you have asthma and use asthma drugs; or you have atopic dermatitis or CRSwNP, and you also have asthma. Do not change or stop your corticosteroid medication or other asthma medications without talking to your healthcare provider. This may cause other symptoms controlled by corticosteroids or other asthma medications to reappear.
DUPIXENT can cause serious side effects, including:
The most common side effects of the indications are as follows:
If you have any side effects that bother you or will not go away, please tell your healthcare provider. These are not all possible side effects of DUPIXENT. Call your doctor and ask for medical advice about side effects. We encourage you to report the side effects of prescription drugs to the FDA. Please visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Use DUPIXENT exactly as specified. Your healthcare provider will tell you how much DUPIXENT to inject and how often. DUPIXENT is a subcutaneous injection (subcutaneous injection). If your healthcare provider decides that you or your caregiver can inject DUPIXENT, you or your caregiver should be trained in the correct way to prepare and inject DUPIXENT. Don't try to inject DUPIXENT until your healthcare provider shows you the right way. For children 12 years and older, it is recommended that DUPIXENT be administered by an adult or under adult supervision. For children under 12 years old, DUPIXENT should be given by a caregiver.
Please refer to the attached complete prescription information, including patient information.
About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-changing drugs for people with serious diseases. Founded and led by doctors and scientists for more than 30 years, our unique ability to repeatedly and consistently translate science into medicine has resulted in nine FDA-approved treatments and numerous product candidates under development, almost all of which are in our Independently developed in the laboratory. Our medicines and pipelines are designed to help patients suffering from eye diseases, allergies and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, blood diseases, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technology, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research Projects, such as the Regeneron Genetics Center, which conducts one of the world's largest gene sequencing tasks.
For more information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
About Sanofi Sanofi is committed to supporting people in dealing with health challenges. We are a global biopharmaceutical company focused on human health. We use vaccines to prevent diseases and provide innovative therapies to fight pain and relieve pain. We support a small number of people with rare diseases and millions of people with long-term chronic diseases.
Sanofi has more than 100,000 employees in 100 countries and is transforming scientific innovations into healthcare solutions on a global scale.
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