Positive Dupixent® (dupilumab) Phase 3 Results in Adults and Adolescents with Eosinophilic Esophagitis Published in the New England Journal of Medicine - Yahoo Finance

1 year ago 52

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

, /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi contiguous announced 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 approval, with a last determination expected successful the coming months.

"The work of these Phase 3 results successful the New England Journal of Medicine reinforces the interaction of the objective proceedings data. These information showed dupilumab 300 mg play substantially decreased diligent symptoms of trouble swallowing, and led to histological illness remission and improvements successful the endoscopic quality of the esophagus, arsenic compared to placebo," said Evan S. Dellon, M.D., M.P.H., Professor of Gastroenterology and Hepatology astatine the University of North Carolina School of Medicine and co-principal researcher of the trial. "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, which was invented utilizing Regeneron's proprietary VelocImmune^® technology, 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.

About Regeneron's VelocImmune Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered rodent level endowed with a genetically humanized immune strategy to nutrient optimized afloat quality antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a postgraduate pupil with his mentor Frederick W. Alt successful 1985, they were the archetypal to envision making specified a genetically humanized mouse, and Regeneron has spent decades inventing and processing VelocImmune and related VelociSuite^® technologies. Dr. Yancopoulos and his squad person utilized VelocImmune exertion to make astir 1 successful 5 of each original, FDA-approved oregon authorized afloat quality monoclonal antibodies. This includes REGEN-COV^® (casirivimab and imdevimab), Dupixent, Libtayo^® (cemiplimab-rwlc), Praluent^® (alirocumab), Kevzara^®(sarilumab), Evkeeza^® (evinacumab-dgnb) and Inmazeb^® (atoltivimab, maftivimab and odesivimab-ebgn).

Dupilumab Development Program
Dupilumab is being jointly developed by Regeneron and Sanofi 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, Regeneron and Sanofi 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.

U.S. INDICATIONS

DUPIXENT is simply a medicine medicine used:

to dainty adults and children 6 months of property and older with moderate-to-severe eczema (atopic dermatitis oregon AD) that is not good controlled with medicine therapies utilized connected the tegument (topical), oregon who cannot usage topical therapies. DUPIXENT tin beryllium utilized with oregon without topical corticosteroids. It is not known if DUPIXENT is harmless and effectual successful children with atopic dermatitis nether 6 months of age.
with different asthma medicines for the attraction attraction of moderate-to-severe eosinophilic oregon oral steroid babelike asthma successful adults and children 6 years of property and older whose asthma is not controlled with their existent asthma medicines. DUPIXENT helps forestall terrible asthma attacks (exacerbations) and tin amended your breathing. DUPIXENT whitethorn besides assistance trim the magnitude of oral corticosteroids you request portion preventing terrible asthma attacks and improving your breathing. DUPIXENT is not utilized to dainty abrupt breathing problems. It is not known if DUPIXENT is harmless and effectual successful children with asthma nether 6 years of age.
with different medicines for the attraction attraction of chronic rhinosinusitis with nasal polyposis (CRSwNP) successful adults whose illness is not controlled. It is not known if DUPIXENT is harmless and effectual successful children with chronic rhinosinusitis with nasal polyposis nether 18 years of age.
to dainty adults and children 12 years of property and older, who measurement astatine slightest 88 pounds (40 kg), with eosinophilic esophagitis (EoE). It is not known if DUPIXENT is harmless and effectual successful children with eosinophilic esophagitis nether 12 years of property and who measurement astatine slightest 88 pounds (40 kg).
to dainty adults with prurigo nodularis (PN). It is not known if DUPIXENT is harmless and effectual successful children with prurigo nodularis nether 18 years of age.

IMPORTANT SAFETY INFORMATION

Do not usage if you are allergic to dupilumab oregon to immoderate of the ingredients successful DUPIXENT^®.

Before utilizing DUPIXENT, archer your healthcare supplier astir each your aesculapian conditions, including if you:

have oculus problems.
have a parasitic (helminth) infection.
are scheduled to person immoderate vaccinations. You should not person a "live vaccine" close earlier and during attraction with DUPIXENT.
are large oregon program to go pregnant. It is not known whether DUPIXENT volition harm your unborn baby.
are breastfeeding oregon program to breastfeed. It is not known whether DUPIXENT passes into your bosom milk.

Tell your healthcare supplier astir each the medicines you take, including medicine and over-the- antagonistic medicines, vitamins, and herbal supplements.

Especially archer your healthcare supplier if you are taking oral, topical, oregon inhaled corticosteroid medicines; person asthma and usage an asthma medicine; oregon person atopic dermatitis, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, oregon prurigo nodularis and besides person asthma. Do not alteration oregon halt your corticosteroid medicine oregon different asthma medicine without talking to your healthcare provider. This whitethorn origin different symptoms that were controlled by the corticosteroid medicine oregon different asthma medicine to travel back.

DUPIXENT tin origin superior broadside effects, including:

Allergic reactions. DUPIXENT tin origin allergic reactions that tin sometimes beryllium severe. Stop utilizing DUPIXENT and archer your healthcare supplier oregon get exigency assistance close distant if you get immoderate of the pursuing signs oregon symptoms: breathing problems oregon wheezing, swelling of the face, lips, mouth, lingua oregon throat, fainting, dizziness, feeling lightheaded, accelerated pulse, fever, hives, associated pain, wide sick feeling, itching, tegument rash, swollen lymph nodes, nausea oregon vomiting, oregon cramps successful your stomach-area.
Eye problems. Tell your healthcare supplier if you person immoderate caller oregon worsening oculus problems, including oculus symptom oregon changes successful vision, specified arsenic blurred vision. Your healthcare supplier whitethorn nonstop you to an ophthalmologist for an exam if needed.
Inflammation of your humor vessels. Rarely, this tin hap successful radical with asthma who person DUPIXENT. This whitethorn hap successful radical who besides instrumentality a steroid medicine by rima that is being stopped oregon the dose is being lowered. It is not known whether this is caused by DUPIXENT. Tell your healthcare supplier close distant if you have: rash, thorax pain, worsening shortness of breath, a feeling of pins and needles oregon numbness of your arms oregon legs, oregon persistent fever.
Joint aches and pain. Some radical who usage DUPIXENT person had occupation walking oregon moving owed to their associated symptoms, and successful immoderate cases needed to beryllium hospitalized. Tell your healthcare supplier astir immoderate caller oregon worsening associated symptoms. Your healthcare supplier whitethorn halt DUPIXENT if you make associated symptoms.

The astir communal broadside effects include:

Eczema: injection tract reactions, oculus and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, acold sores successful your rima oregon connected your lips, and precocious number of a definite achromatic humor compartment (eosinophilia).
Asthma: injection tract reactions, precocious number of a definite achromatic humor compartment (eosinophilia), symptom successful the pharynx (oropharyngeal pain), and parasitic (helminth) infections.
Chronic Rhinosinusitis with Nasal Polyposis: injection tract reactions, oculus and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, precocious number of a definite achromatic humor compartment (eosinophilia), gastritis, associated symptom (arthralgia), occupation sleeping (insomnia), and toothache.
Eosinophilic Esophagitis: injection tract reactions, precocious respiratory tract infections, acold sores successful your rima oregon connected your lips, and associated symptom (arthralgia).
Prurigo Nodularis: oculus and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, herpes microorganism infections, communal acold symptoms (nasopharyngitis), dizziness, musculus pain, and diarrhea.

Tell your healthcare supplier if you person immoderate broadside effect that bothers you oregon that does not spell away. These are not each the imaginable broadside effects of DUPIXENT. Call your doc for aesculapian proposal astir broadside effects. You are encouraged to study antagonistic broadside effects of medicine drugs to the FDA. Visit www.fda.gov/medwatch, oregon telephone 1-800-FDA-1088.

Use DUPIXENT precisely arsenic prescribed by your healthcare provider. It's an injection fixed nether the tegument (subcutaneous injection). Your healthcare supplier volition determine if you oregon your caregiver tin inject DUPIXENT. Do not try to hole and inject DUPIXENT until you oregon your caregiver person been trained by your healthcare provider. In children 12 years of property and older, it's recommended DUPIXENT beryllium administered by oregon nether supervision of an adult. In children 6 months to little than 12 years of age, DUPIXENT should beryllium fixed by a caregiver.

Please spot accompanying afloat Prescribing Information including Patient Information.

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 or 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

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 oregon immoderate imaginable regulatory support of Regeneron's Products and Regeneron's Product Candidates; 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 as Dupixent for the attraction of adults and adolescents with EoE based connected the European Medicines Agency submission referenced successful this property release, arsenic good arsenic for the attraction of 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, bullous pemphigoidand, 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).

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.