Dupixent® (dupilumab) approved by European Commission arsenic the archetypal and lone targeted medicine indicated for eosinophilic esophagitis
- Approximately 60% of patients aged 12 years and older treated with Dupixent 300 mg play successful the pivotal proceedings experienced histological illness remission; patients besides importantly improved their quality to swallow compared to placebo
- Dupixent is present an enactment for the astir 50,000 adults and adolescents surviving with terrible uncontrolled eosinophilic esophagitis successful the European Union (EU)
- Dupixent present approved to dainty 5 diseases with underlying benignant 2 inflammation successful the EU
Paris and Tarrytown, N.Y. Jan 30, 2023. The European Commission (EC) has expanded the selling authorization for Dupixent® (dupilumab) successful the European Union (EU) to dainty eosinophilic esophagitis (EoE) successful adults and adolescents 12 years and older, weighing astatine slightest 40 kg, who are inadequately controlled by, are intolerant to, oregon who are not candidates for accepted medicinal therapy. EoE is simply a chronic, progressive inflammatory illness that damages the esophagus and prevents it from moving properly. With this approval, Dupixent is the archetypal and lone targeted medicine specifically indicated to dainty EoE successful Europe and the U.S.
Naimish Patel, M.D.
Head of Global Development, Immunology and Inflammation at Sanofi
“The interaction of EoE connected a patient’s regular beingness cannot beryllium overstated – the narrowing and scarring of the esophagus tin marque thing arsenic elemental arsenic eating a achy and distressing experience, and whitethorn pb to choking and nutrient impaction. With this latest support for Dupixent, adults and adolescents successful the EU suffering from the chronic and often debilitating symptoms of EoE present person the archetypal and lone targeted attraction enactment clinically proven to trim some esophageal inflammation and damage, arsenic good arsenic amended swallowing ability, symptom and health-related prime of life.”
George D. Yancopoulos, M.D., Ph.D.
President and Chief Scientific Officer astatine Regeneron
“This latest support establishes Dupixent arsenic the lone targeted medicine specifically indicated for eosinophilic esophagitis successful the European Union. Dupixent is besides the lone biologic shown successful pivotal trials to assistance patients execute histological remission, trim trouble swallowing and amended health-related prime of beingness – each of which are important to reducing the load of this debilitating disease. Since its archetypal approval, Dupixent has redefined the attraction of certain chronic diseases with underlying benignant 2 inflammation and is present indicated for 5 conditions successful the European Union. We stay committed to investigating Dupixent’s imaginable successful further diseases successful which IL-4 and IL-13 whitethorn play a cardinal role.”
The EC determination is supported by 52-week information from a Phase 3 proceedings consisting of 3 parts (Part A, B and C). Part A and Part B investigated Dupixent 300 mg play (Part A n=42; Part B n=80) compared to placebo (Part A n=39; Part B n=79) for 24 weeks. Part C (n=188) observed patients who had continued connected oregon switched to Dupixent from Parts A and B for an further 28 weeks.
Dupixent patients successful Parts A and B, respectively, experienced:
- An astir 10 times higher complaint of histological illness remission (60% and 59%), a co-primary endpoint, compared to placebo (5% and 6%).
- A 69% and 64% simplification successful illness symptoms compared to 32% and 41% with placebo. Disease symptoms were measured utilizing the Dysphagia Symptom Questionnaire (DSQ), connected which Dupixent patients experienced a 21.9- and 23.8-point clinically meaningful betterment compared to a 9.6- and 13.9-point betterment for placebo, a co-primary endpoint. Swallowing betterment was observed arsenic aboriginal arsenic 4 weeks.
- A greater than seven-fold simplification successful abnormal endoscopic findings from baseline (-3.2 and -4.5 points) compared to placebo (-0.3 and -0.6 points).
- Nominally important improvements successful swallowing-related symptom and health-related prime of life, arsenic good arsenic little predominant non-swallowing symptoms.
Histological illness remission, swallowing betterment and simplification successful abnormal endoscopic findings were accordant with the wide colonisation successful patients who were uncontrolled, oregon not responsive to oregon not eligible for swallowed topical corticosteroids. Longer word efficacy successful Part C was akin to results observed successful Parts A and B.
The information results of the proceedings were mostly accordant with the known information illustration of Dupixent successful its approved indications. The astir communal broadside effects crossed indications see injection tract reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes and eosinophilia. Adverse events much commonly observed successful EoE patients treated with Dupixent (n=122) compared to placebo (n=117) included infections (32% vs. 25%). An further adverse absorption of injection tract bruising was reported successful the EoE trial. The information illustration done 52 weeks was mostly accordant with the information illustration observed astatine 24 weeks.
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. In the EU, astir 50,000 adults and adolescents unrecorded with terrible uncontrolled EoE.
About the Dupixent Eosinophilic Esophagitis Trial
The three-part Phase 3 randomized, double-blind, placebo-controlled proceedings evaluated the efficacy and information of Dupixent successful patients aged 12 years and older with EoE. All patients had antecedently not responded to proton pump inhibitors, and, crossed Parts A and B, 74% of patients were antecedently treated with swallowed topical corticosteroids.
At 24 weeks, the co-primary endpoints successful Parts A and B assessed patient-reported measures of trouble swallowing (change from baseline successful the DSQ connected a 0-84 scale) and esophageal inflammation (proportion of patients achieving histological illness remission, defined arsenic highest esophageal intraepithelial eosinophil number of ≤6 eos/hpf).
Additional endpoints included abnormal endoscopic findings (EoE Endoscopic Reference Score [EoE-EREFS] connected a 0-18 scale), swallowing-related symptom (DSQ symptom score), health-related prime of beingness (EoE Impact Questionnaire [EoE-IQ]) and frequence of different non-dysphagia symptoms (EoE Symptom Questionnaire [EoE-SQ]).
About Dupixent
Dupixent is an injection administered nether the tegument (subcutaneous injection) astatine antithetic injection sites. In the EU for adolescents and adults with EoE, Dupixent is administered astatine 300 mg each week. It is disposable arsenic some a pre-filled pen and pre-filled syringe astatine the 300 mg dose. Dupixent is intended for usage nether the guidance of a healthcare nonrecreational and tin beryllium fixed successful a session oregon astatine location by self-administration aft grooming by a healthcare professional.
Dupixent is simply a afloat quality 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 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 atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis and EoE.
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 prurigo nodularis successful antithetic property populations. Dupixent is presently approved for 1 oregon much of these indications successful much than 60 countries, including successful Europe, the U.S. 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 pruritus 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 (NASDAQ: REGN) is simply a starring biotechnology institution that invents, develops and commercializes life-transforming medicines for radical with superior diseases. Founded and led for 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
Sanofi Media Relations
Sally Bain | + 1 617 834 6026 | sally.bain@sanofi.com
Sanofi Investor Relations
Eva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com
Arnaud Delépine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com
Corentine Driancourt | + 33 06 40 56 92 21 | corentine.driancourt@sanofi.com
Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com
Priya Nanduri |+ 1 617 764 6418 | priya.nanduri@sanofi.com
Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com
Regeneron Media Relations
Ilana Yellen | + 1 914 330 9618 |ilana.yellen@regeneron.com
Regeneron Investor Relations
Vesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com
Sanofi Disclaimers oregon Forward-Looking Statements
This property merchandise contains forward-looking statements arsenic defined successful the Private Securities Litigation Reform Act of 1995, arsenic amended. Forward-looking statements are statements that are not humanities facts. These statements see projections and estimates regarding the selling and different imaginable of the product, oregon regarding imaginable aboriginal revenues from the product. Forward-looking statements are mostly identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and akin expressions. Although Sanofi's absorption believes that the expectations reflected successful specified forward-looking statements are reasonable, investors are cautioned that forward-looking accusation and statements are taxable to assorted risks and uncertainties, galore of which are hard to foretell and mostly beyond the power of Sanofi, that could origin existent results and developments to disagree materially from those expressed in, oregon implied oregon projected by, the forward-looking accusation and statements. These risks and uncertainties see among different things, unexpected regulatory actions oregon delays, oregon authorities regularisation generally, that could impact the availability oregon commercialized imaginable of the product, the information that merchandise whitethorn not beryllium commercially successful, the uncertainties inherent successful probe and development, including aboriginal objective information and investigation of existing objective information relating to the product, including station marketing, unexpected safety, prime oregon manufacturing issues, contention successful general, risks associated with intelligence spot and immoderate related aboriginal litigation and the eventual result of specified litigation, and volatile economical and marketplace conditions, and the interaction that COVID-19 volition person connected us, our customers, suppliers, vendors, and different concern partners, and the fiscal information of immoderate 1 of them, arsenic good arsenic connected our employees and connected the planetary system arsenic a whole. Any worldly effect of COVID-19 connected immoderate of the foregoing could besides adversely interaction us. This concern is changing rapidly and further impacts whitethorn originate of which we are not presently alert and whitethorn exacerbate different antecedently identified risks. The risks and uncertainties besides see the uncertainties discussed oregon identified successful the nationalist filings with the SEC and the AMF made by Sanofi, including those listed nether "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" successful Sanofi's yearly study connected Form 20-F for the twelvemonth ended December 31, 2021. Other than arsenic required by applicable law, Sanofi does not undertake immoderate work to update oregon revise immoderate forward-looking accusation oregon statements.
Regeneron Forward-Looking Statements and Use of Digital Media
This property merchandise includes forward-looking statements that impact risks and uncertainties relating to aboriginal events and the aboriginal show of Regeneron Pharmaceuticals, Inc. (“Regeneron” oregon the “Company”), and existent events oregon results whitethorn disagree materially from these forward-looking statements. Words specified arsenic “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of specified words, and akin expressions are intended to place specified forward-looking statements, though not each forward-looking statements incorporate these identifying words. These statements concern, and these risks and uncertainties include, among others, the interaction of SARS-CoV-2 (the microorganism that has caused the COVID-19 pandemic) connected Regeneron’s concern and its employees, collaborators, and suppliers and different 3rd parties connected which Regeneron relies, Regeneron’s and its collaborators’ quality to proceed to behaviour probe and objective programs, Regeneron’s quality to negociate its proviso chain, nett merchandise income of products marketed oregon different commercialized by Regeneron and/or its collaborators oregon licensees (collectively, “Regeneron’s Products”), and the planetary economy; the nature, timing, and imaginable occurrence and therapeutic applications of Regeneron’s Products and merchandise candidates being developed by Regeneron and/or its collaborators oregon licensees (collectively, “Regeneron’s Product Candidates”) and probe and objective programs present underway oregon planned, including without regulation Dupixent® (dupilumab) for the attraction of adults and adolescents with eosinophilic esophagitis (“EoE”); uncertainty of the utilization, marketplace acceptance, and commercialized occurrence of Regeneron’s Products and Regeneron’s Product Candidates and the interaction of studies (whether conducted by Regeneron oregon others and whether mandated oregon voluntary), including the studies discussed oregon referenced successful this property release, connected immoderate of the foregoing; the likelihood, timing, and scope of imaginable regulatory support and commercialized motorboat of Regeneron’s Product Candidates and caller indications for Regeneron’s Products, specified arsenic Dupixent for the attraction of pediatric EoE, manus and ft atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of chartless origin, chronic obstructive pulmonary illness with grounds of benignant 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, bullous pemphigoid, and different imaginable indications; the quality of Regeneron’s collaborators, licensees, suppliers, oregon different 3rd parties (as applicable) to execute manufacturing, filling, finishing, packaging, labeling, distribution, and different steps related to Regeneron’s Products and Regeneron’s Product Candidates; the quality of Regeneron to negociate proviso chains for aggregate products and merchandise candidates; information issues resulting from the medication of Regeneron’s Products (such arsenic Dupixent) and Regeneron’s Product Candidates successful patients, including superior complications oregon broadside effects successful transportation with the usage of Regeneron’s Products and Regeneron’s Product Candidates successful objective trials; determinations by regulatory and administrative governmental authorities which whitethorn hold oregon restrict Regeneron’s quality to proceed to make oregon commercialize Regeneron’s Products and Regeneron’s Product Candidates, including without regulation Dupixent; ongoing regulatory obligations and oversight impacting Regeneron’s Products, probe and objective programs, and business, including those relating to diligent privacy; the availability and grade of reimbursement of Regeneron’s Products from third-party payers, including backstage payer healthcare and security programs, wellness attraction organizations, pharmacy payment absorption companies, and authorities programs specified arsenic Medicare and Medicaid; sum and reimbursement determinations by specified payers and caller policies and procedures adopted by specified payers; competing drugs and merchandise candidates that whitethorn beryllium superior to, oregon much outgo effectual than, Regeneron’s Products and Regeneron’s Product Candidates; the grade to which the results from the probe and improvement programs conducted by Regeneron and/or its collaborators oregon licensees whitethorn beryllium replicated successful different studies and/or pb to advancement of merchandise candidates to objective trials, therapeutic applications, oregon regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the quality of Regeneron to conscionable immoderate of its fiscal projections oregon guidance and changes to the assumptions underlying those projections oregon guidance; the imaginable for immoderate license, collaboration, oregon proviso agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, arsenic applicable) to beryllium cancelled oregon terminated; and risks associated with intelligence spot of different parties and pending oregon aboriginal litigation relating thereto (including without regulation the patent litigation and different related proceedings relating to EYLEA® (aflibercept) Injection, Praluent® (alirocumab), and REGEN-COV® (casirivimab and imdevimab)), different litigation and different proceedings and authorities investigations relating to the Company and/or its operations, the eventual result of immoderate specified proceedings and investigations, and the interaction immoderate of the foregoing whitethorn person connected Regeneron’s business, prospects, operating results, and fiscal condition. A much implicit statement of these and different worldly risks tin beryllium recovered successful Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the twelvemonth ended December 31, 2021 and its Form 10-Q for the quarterly play ended September 30, 2022. Any forward-looking statements are made based connected management’s existent beliefs and judgment, and the scholar is cautioned not to trust connected immoderate forward-looking statements made by Regeneron. Regeneron does not undertake immoderate work to update (publicly oregon otherwise) immoderate forward-looking statement, including without regulation immoderate fiscal projection oregon guidance, whether arsenic a effect of caller information, aboriginal events, oregon otherwise.
Regeneron uses its media and capitalist relations website and societal media outlets to people important accusation astir the Company, including accusation that whitethorn beryllium deemed worldly to investors. Financial and different accusation astir Regeneron is routinely posted and is accessible connected Regeneron’s media and capitalist relations website (http://newsroom.regeneron.com) and its Twitter provender (http://twitter.com/regeneron).
English (US)