New England Journal of Medicine publishes positive Phase 3 Dupixent (dupilumab) results in children with moderate-to-severe asthma
- Dupixent significantly reduced severe asthma attacks and improved lung function and asthma control in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma
- Published results reinforce well-established safety profile of Dupixent
- Positive data formed the basis for FDA approval of Dupixent in these patients with certain types of moderate-to-severe asthma and regulatory reviews are ongoing in the European Union
PARIS and TARRYTOWN, N.Y. - December 8, 2021 - The New England Journal of Medicine has published (https://www.nejm.org/doi/full/10.1056/NEJMoa2106567) positive results from a pivotal Dupixent (dupilumab) clinical trial in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. These data formed the basis for the FDA approval (https://www.news.sanofi.us/2021-10-20-FDA-expands-approval-of-Dupixent-R-dupilumab-to-include-children-aged-6-to-11-years-with-moderate-to-severe-asthma) of Dupixent on October 20, 2021 as an add-on maintenance treatment of patients aged 6 to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma.
These published results showed Dupixent, when added to standard of care, significantly reduced severe asthma attacks and, within two weeks, rapidly improved lung function in populations with an eosinophilic phenotype, as indicated by elevated blood eosinophils, a certain type of white blood cell, and/or with elevated fractional exhaled nitric oxide (FeNO), an airway biomarker of inflammation that plays a major role in asthma.
"The publication of thesePhase 3 results for Dupixent in the New England Journal of Medicine underscore their significance and potential clinical value for younger children with uncontrolled moderate-to-severe asthma," says Leonard B. Bacharier, M.D., Professor of Pediatrics and Director of the Center for Pediatric Asthma Research, Monroe Carell Jr. Children's Hospital at Vanderbilt University Medical Center in Nashville, Tennessee, and principal investigator of the trial. "These data also further our understanding of how addressing type 2 inflammation, a biological process that underlies most cases of childhood asthma, can potentially improve symptoms and outcomes for children suffering from this common chronic disease."
Asthma is one of the most common chronic diseases in children. Approximately 75,000 children aged 6 to 11 years live with the uncontrolled moderate-to-severe form of the disease in the U.S., and many more worldwide. Despite treatment with current standard-of-care inhaled corticosteroids and bronchodilators, these children may continue to experience serious symptoms such as coughing, wheezing and difficulty breathing. They also may require multiple courses of systemic corticosteroids that can carry significant safety risks.
The safety results from the trial were generally consistent with the known safety profile of Dupixent in patients aged 12 years and older with uncontrolled moderate-to-severe asthma, with the addition of helminth infections that were reported in 2.2% of Dupixent patients and 0.7% of placebo patients. The overall rates of adverse events were 83% for Dupixent and 80% for placebo. The most common adverse events that were more commonly observed with Dupixent compared to placebo were injection site reactions (18% Dupixent, 13% placebo), viral upper respiratory tract infections (12% Dupixent, 10% placebo) and eosinophilia (6% Dupixent, 1% placebo).
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. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP).
The results of this Phase 3 trial were also included in the European regulatory filing, and a decision from the European Medicines Agency in children with uncontrolled severe asthma is expected in Q1 2022.
About the LIBERTY ASTHMA VOYAGE trial
The Phase 3 randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent (100 mg for children =30 kg or 200 mg for children >30 kg every two weeks) combined with standard-of-care asthma therapy in 408 children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. The primary endpoint was the annualized rate of severe asthma exacerbations over one year and the key secondary endpoint was the change from baseline in percentage of predicted pre-bronchodilator FEV1 (ppFEV1) at week 12.
Dupixent is currently approved in the U.S., Europe, Japan and other countries around the world for use in specific patients with moderate-to-severe atopic dermatitis, as well as certain patients with asthma or CRSwNP in different age populations. Dupixent is also approved in one or more of these indications in more than 60 countries around the world and more than 300,000 patients have been treated globally.
Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home by self-administration after training by a healthcare professional. In children younger than 12 years of age, Dupixent should be administered by a caregiver.
Dupilumab Development Program
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across 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, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes, including chronic obstructive pulmonary disease with evidence of type 2 inflammation (Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), eosinophilic esophagitis (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), chronic inducible urticaria-cold (Phase 3), chronic rhinosinusitis without nasal polyposis (Phase 3), allergic fungal rhinosinusitis (Phase 3), allergic bronchopulmonary aspergillosis (Phase 3) and peanut allergy (Phase 2). 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.
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Regeneron is accelerating and improving the traditional drug development process through our 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.
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- Sanofi Global_Dupixent NEJM Press Release_FINAL (https://ml-eu.globenewswire.com/Resource/Download/1e657d60-793a-4b9e-ae7d-05f9234cabc1)