Positive Dupixent® (dupilumab) Phase 3 results successful adults and adolescents with eosinophilic esophagitis published successful the New England Journal of Medicine
Dupixent 300 mg play showed important histological illness remission and betterment successful symptoms of the illness compared to placebo
Improvements were sustained for up to 1 twelvemonth successful patients aged 12 years and older with eosinophilic esophagitis (EoE)
Dupixent is the archetypal and lone targeted medicine indicated successful the U.S. to dainty EoE patients aged 12 and older weighing astatine slightest 40 kg
Paris and Tarrytown, N.Y. DECEMBER 21, 2022 The New England Journal of Medicine has published results from a affirmative Phase 3 proceedings showing adults and adolescents treated with Dupixent® (dupilumab) 300 mg play experienced important improvements successful signs and symptoms of eosinophilic esophagitis (EoE), which were sustained for up to 1 year.
EoE is simply a chronic, progressive inflammatory illness that damages the esophagus and prevents it from moving properly. These information formed the ground for the U.S. Food and Drug Administration (FDA) approval of Dupixent successful May 2022, making it the archetypal and lone medicine indicated to dainty patients with EoE aged 12 years and older, weighing astatine slightest 40 kg. These Phase 3 information person been submitted to the European Medicines Agency (EMA) to enactment regulatory support for adults and adolescents with EoE. The EMA’s Committee for Medicinal Products for Human Use precocious adopted a affirmative sentiment recommending support with a last determination expected successful the coming months.
Evan S. Dellon, M.D., M.P.H.
Professor of Gastroenterology and Hepatology astatine the University of North Carolina School of Medicine
“The work of these Phase 3 results successful the New England Journal of Medicine reinforces the impact of the clinical trial data. These information showed dupilumab 300 mg play substantially decreased patient symptoms of trouble swallowing, and led to histological illness remission and improvements successful the endoscopic quality of the esophagus, arsenic compared to placebo. These information besides underscore the relation of inhibiting the IL-4 and IL-13 pathways successful eosinophilic esophagitis with dupilumab, adding to our increasing cognition of this poorly understood disease.”
As published, patients received Dupixent 300 mg either play oregon each 2 weeks successful the Phase 3 trial. Patients receiving Dupixent play experienced betterment successful the quality to swallow and achieved histological illness remission. Additionally, these patients experienced improved anatomic, cellular, molecular and health-related prime of beingness measures, with improvements successful signs and symptoms of EoE sustained for up to 1 year. Patients treated with Dupixent each 2 weeks experienced histological illness remission but did not acquisition betterment successful the quality to swallow. The existent FDA-approved dosage for Dupixent arsenic a attraction for children and adults aged 12 years and older with EoE, weighing astatine slightest 40 kg, is 300 mg weekly.
The information results were mostly accordant with the known information illustration of Dupixent successful its approved indications. Adverse events (≥5%) that were much commonly observed with Dupixent included injection tract reactions, nasopharyngitis and rash.
About Eosinophilic Esophagitis
EoE is simply a chronic, progressive inflammatory illness that damages the esophagus and prevents it from moving properly. The results seen with Dupixent successful adults and adolescents with EoE show that interleukin-4 (IL-4) and interleukin-13 (IL-13) are cardinal and cardinal drivers of the benignant 2 inflammation underlying this disease. For radical with EoE, swallowing adjacent tiny amounts of nutrient tin beryllium a achy and worrisome choking experience. They are often near to contend with the vexation and anxiousness of a perpetually evolving database of foods to avoid, a mediocre prime of beingness and a higher hazard of depression. In cases wherever EoE causes the esophagus to narrow, forced and perchance achy dilation (physical expansion) of the esophagus whitethorn beryllium needed. In terrible cases, a feeding conduit whitethorn beryllium the lone enactment to guarantee due caloric intake and capable nutrition. Of the astir 209,000 patients aged 12 years and older surviving with EoE successful the U.S. who are presently treated with therapies not specifically approved for the disease, astir 42,000 proceed to acquisition symptoms contempt aggregate treatments.
About the Dupixent Eosinophilic Esophagitis Trial
The Phase 3 randomized, double-blind, placebo-controlled proceedings evaluated the efficacy and information of Dupixent successful patients aged 12 years and older with EoE successful 3 parts. Part A enrolled 81 patients and evaluated Dupixent 300 mg play for 24 weeks. Part B enrolled 240 patients and evaluated Dupixent 300 mg play and each 2 weeks for 24 weeks. Parts A and B were designed likewise and consisted of abstracted diligent groups. All patients successful Parts A and B had an enactment to enactment successful Part C for an further 28 weeks, for up to 52 weeks of Dupixent treatment. Part C enrolled 77 patients from Part A.
At 24 weeks, the co-primary endpoints successful Parts A and B assessed patient-reported measures of trouble swallowing and esophageal inflammation. The secondary endpoints included assessments of histopathologic measures of the severity and grade of further histological measures successful the esophagus, and different measures. In Part C, each superior and secondary endpoints assessed successful Parts A and B were assessed arsenic secondary endpoints astatine 52 weeks.
About Dupixent
Dupixent is simply a afloat quality monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways and is not an immunosuppressant. The Dupixent improvement programme has shown important objective payment and a alteration successful benignant 2 inflammation successful Phase 3 trials, establishing that IL-4 and IL-13 are cardinal and cardinal drivers of the benignant 2 inflammation that plays a large relation successful aggregate related and often co-morbid diseases. These diseases see approved indications for Dupixent specified arsenic asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyposis (CRSwNP), EoE and prurigo nodularis (PN).
Dupixent has received regulatory approvals successful 1 oregon much countries astir the satellite for usage successful definite patients with atopic dermatitis, asthma, CRSwNP, EoE oregon PN successful antithetic property populations. Dupixent is presently approved crossed these indications successful the U.S. and for 1 oregon much of these indications successful much than 60 countries, including successful the European Union and Japan. More than 500,000 patients person been treated with Dupixent globally.
Dupilumab Development Program
Dupilumab is being jointly developed by Sanofi and Regeneron nether a planetary collaboration agreement. To date, dupilumab has been studied crossed much than 60 objective trials involving much than 10,000 patients with assorted chronic diseases driven successful portion by benignant 2 inflammation.
In summation to the presently approved indications, Sanofi and Regeneron are studying dupilumab successful a wide scope of diseases driven by benignant 2 inflammation oregon different allergic processes successful Phase 3 trials, including pediatric EoE, manus and ft atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritis of chartless origin, chronic obstructive pulmonary illness with grounds of benignant 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These imaginable uses of dupilumab are presently nether objective investigation, and the information and efficacy successful these conditions person not been afloat evaluated by immoderate regulatory authority.
About Regeneron
Regeneron is simply a starring biotechnology institution that invents, develops and commercializes life-transforming medicines for radical with superior diseases. Founded and led for astir 35 years by physician-scientists, our unsocial quality to repeatedly and consistently construe subject into medicine has led to 9 FDA-approved treatments and galore merchandise candidates successful development, astir each of which were homegrown successful our laboratories. Our medicines and pipeline are designed to assistance patients with oculus diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and uncommon diseases.
Regeneron is accelerating and improving the accepted cause improvement process done our proprietary VelociSuite® technologies, specified arsenic VelocImmune®, which uses unsocial genetically humanized mice to nutrient optimized afloat quality antibodies and bispecific antibodies, and done ambitious probe initiatives specified arsenic the Regeneron Genetics Center, which is conducting 1 of the largest genetics sequencing efforts successful the world.
For much information, delight sojourn www.Regeneron.com oregon travel @Regeneron connected Twitter.
About Sanofi
We are an innovative planetary healthcare company, driven by 1 purpose: we pursuit the miracles of subject to amended people’s lives. Our team, crossed immoderate 100 countries, is dedicated to transforming the signifier of medicine by moving to crook the intolerable into the possible. We supply perchance life-changing attraction options and life-saving vaccine extortion to millions of radical globally, portion putting sustainability and societal work astatine the halfway of our ambitions.
Sanofi is listed connected EURONEXT: SAN and NASDAQ: SNY.
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