Approval for kids aged 2 to 11 years with CSU who stay symptomatic regardless of H1 antihistamine remedy primarily based totally on information from the LIBERTY-CUPID scientific trial program
CSU is a power pores and skin illness that causes itch and hives that may be debilitating for younger youngsters, particularly for these whose illness stays uncontrolled
CSU marks the fifth illness pushed partially by sort 2 irritation for which Dupixent is authorized in youngsters youthful than 12 years of age
TARRYTOWN, N.Y. and PARIS, April 22, 2026 (GLOBE NEWSWIRE) — Regeneron Prescribed drugs, Inc. (NASDAQ: REGN) and Sanofi right this moment introduced that the U.S. Meals and Drug Administration (FDA) has authorized Dupixent® (dupilumab) for the remedy of kids aged 2 to 11 years with power spontaneous urticaria (CSU) who stay symptomatic regardless of histamine-1 antihistamine (H1AH) remedy. This expands the earlier approval for Dupixent in adults and adolescents aged 12 years and older with CSU.
“With this approval, Dupixent has become the first biologic medicine in the U.S. for young children suffering from uncontrolled chronic spontaneous urticaria, an unpredictable skin disease that impacts quality of life during these children’s most formative years,” mentioned George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent. “Dupixent is now approved for nine different allergy-related conditions, from asthma to atopic dermatitis, and this is the fifth of these indications now extended to young children. The FDA’s authorization reinforces our medicine’s well-established safety profile and potential to transform outcomes for chronic diseases driven in part by type 2 inflammation impacting some of the most vulnerable populations. As the most widely used innovative branded antibody medicine, Dupixent has the potential to change yet another treatment paradigm.”
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The approval relies totally on information from the LIBERTY-CUPID scientific trial program. This contains extrapolation of efficacy and security information from two Section 3 trials (Examine A and Examine C) in sure adults and adolescents aged 12 years and older with CSU complemented with pharmacokinetics information from the single-arm, CUPIDKids Section 3 trial in youngsters aged 2 to 11 years with CSU. In Examine A and Examine C, Dupixent considerably diminished itch severity and urticaria exercise (a composite of itch and hives) in comparison with placebo at week 24. In adults and adolescents, Dupixent additionally elevated the probability of well-controlled illness or full response in comparison with placebo at week 24. Examine B offered further security information and evaluated Dupixent in sufferers aged 12 years and older who had been insufficient responders or illiberal to anti-IgE remedy and symptomatic regardless of antihistamine use. Security in youngsters aged 2 to 11 years with CSU was supported by information from pediatric sufferers in different indications.
The security outcomes from all 4 CSU trials had been typically according to the identified security profile of Dupixent in its authorized dermatological indications. In Examine A, Examine B and Examine C, the most typical hostile response (≥2%) within the U.S. Prescribing Data extra steadily noticed in sufferers on Dupixent in comparison with placebo was injection web site reactions. No new hostile reactions had been recognized in youngsters aged 2 to 11 years with CSU handled with Dupixent.
“Children with uncontrolled chronic spontaneous urticaria continue to experience the unpredictable appearance of debilitating itch and hives,” mentioned Alyssa Johnsen, M.D., Ph.D., World Therapeutic Space Head, Immunology Growth at Sanofi. “Until now, these patients had to rely on limited treatment options that didn’t address potential critical mediators of chronic spontaneous urticaria. Dupixent is the first biologic approved for patients as young as 2 years of age, offering a targeted approach that inhibits IL-4 and IL-13 signaling, two key and central drivers of the type 2 inflammation that contributes to this disease. Today’s approval underscores our ongoing commitment to advancing therapies for young patients with significant unmet needs.”
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Along with the U.S., Dupixent is authorized for CSU in sure youngsters aged 2 to 11 years within the EU and different nations world wide.
About CSUCSU is a power inflammatory pores and skin illness pushed partially by sort 2 irritation, which causes sudden and debilitating hives and recurring itch. CSU is often handled with H1AH, medicines that focus on H1 receptors on cells to regulate signs of itch and urticaria. Nonetheless, the illness stays uncontrolled regardless of H1AH remedy in additional than 14,000 youngsters within the U.S. aged 2 to 11 years dwelling with CSU, a few of whom are left with restricted various remedy choices. These people proceed to expertise signs that may be debilitating and considerably affect their high quality of life.
In regards to the Dupixent CSU Section 3 Trial ProgramThe LIBERTY-CUPID Section 3 program evaluating Dupixent for CSU in youngsters aged 2 to 11 years consists of CUPIDKids, Examine A, Examine B and Examine C. CUPIDKids was a single arm scientific trial that assessed the security, efficacy and pharmacokinetics of Dupixent in youngsters aged 2 to 11 years with CSU who remained symptomatic regardless of using antihistamines. Through the 24-week remedy interval, Dupixent was administered at 200 mg each two or 4 weeks or 300 mg each 4 weeks, with or with out an preliminary loading dose, primarily based on age and weight. The first endpoint measured the serum focus of Dupixent over time, together with Ctrough (lowest focus earlier than the following dose) at week 12 and week 24.
Examine A and Examine C had been replicate, double-blind, placebo-controlled scientific trials that assessed Dupixent as an add-on remedy to standard-of-care antihistamines in comparison with antihistamines alone in sufferers aged 6 years and older who remained symptomatic regardless of using antihistamines and had been naïve to anti-IgE remedy. Examine B was carried out in sufferers aged 12 years and older who had been symptomatic regardless of use of antihistamines and had been insufficient responders or illiberal to anti-IgE remedy. Through the 24-week remedy interval in all three trials, all sufferers acquired an preliminary loading dose adopted by both 300 mg Dupixent each two weeks or, for pediatric sufferers weighing 30 kg to <60 kg, 200 mg each two weeks. In each trials, endpoints assessed at week 24 included:
Change from baseline in itch (measured by the weekly itch severity rating [ISS7], 0-21 scale), the first endpoint.Change from baseline in itch and hives (weekly urticaria exercise rating [UAS7], 0-42 scale), the important thing secondary endpoint.Proportion of sufferers attaining well-controlled illness standing (UAS7 ≤6).Proportion of sufferers with full response (UAS7=0).
About DupixentDupixent is an injection administered underneath the pores and skin (subcutaneous injection) at totally different injection websites. In youngsters aged 2 to 11 years with CSU who stay symptomatic regardless of H1 antihistamine remedy, Dupixent is run primarily based on age and weight. In youngsters aged 2 to five years, Dupixent is run at 200 mg each 4 weeks for sufferers weighing ≥5 kg to <15 kg and 300 mg each 4 weeks for ≥15 kg to <30 kg, with out an preliminary loading dose. In youngsters aged 6 to 17 years, Dupixent is run at 300 mg each 4 weeks for ≥15 kg to <30 kg, 200 mg each two weeks for ≥30 kg to <60 kg and 300 mg each two weeks for ≥60 kg, after an preliminary loading dose. Dupixent is meant to be used underneath the steering of a healthcare skilled and could be given in a clinic or at house after coaching by a healthcare skilled. In youngsters aged 2 to 11 years, Dupixent needs to be administered by a caregiver if given at house.
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Dupixent, which was invented utilizing Regeneron’s proprietary VelocImmune® expertise, is a completely human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and isn’t an immunosuppressant. The Dupixent growth program has proven vital scientific profit and a lower in sort 2 irritation in Section 3 trials, establishing that IL-4 and IL-13 are two of the important thing and central drivers of the sort 2 irritation that performs a serious position in a number of associated and sometimes co-morbid illnesses.
Regeneron and Sanofi are dedicated to serving to sufferers within the U.S. who’re prescribed Dupixent acquire entry to the drugs and obtain the assist they could want with the DUPIXENT MyWay® program. For extra info, please name 1-844-DUPIXENT (1-844-387-4936) or go to www.DUPIXENT.com.
Dupixent has acquired regulatory approvals in additional than 60 nations in a number of indications together with sure sufferers with atopic dermatitis, bronchial asthma, power rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis, CSU, power obstructive pulmonary illness (COPD), bullous pemphigoid (BP) and allergic fungal rhinosinusitis (AFRS) in numerous age populations. Greater than 1,400,000 sufferers are being handled with Dupixent globally.1
About Regeneron’s VelocImmune TechnologyRegeneron’s VelocImmune expertise makes use of a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to provide optimized absolutely human antibodies. When Regeneron’s co-Founder, Board co-Chair, President and Chief Scientific Officer George D. Yancopoulos was a graduate pupil together with his mentor Frederick W. Alt in 1985, they had been the primary to check making such a genetically humanized mouse, and Regeneron has spent a long time inventing and growing VelocImmune and associated VelociSuite® applied sciences. Dr. Yancopoulos and his staff have used VelocImmune expertise to create a considerable proportion of all authentic, FDA-approved absolutely human monoclonal antibodies. This contains Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). As well as, REGEN-COV® (casirivimab and imdevimab) had been approved by the FDA in the course of the COVID-19 pandemic till 2024.
Dupilumab Growth ProgramDupilumab is being collectively developed by Regeneron and Sanofi underneath a worldwide collaboration settlement. To this point, dupilumab has been studied throughout greater than 60 scientific trials involving greater than 12,000 sufferers with varied power illnesses pushed partially by sort 2 irritation.
Along with the presently authorized indications, Regeneron and Sanofi are finding out dupilumab in a broad vary of illnesses pushed by sort 2 irritation or different allergic processes in Section 3 trials, together with power pruritus of unknown origin and lichen simplex chronicus. These potential makes use of of dupilumab are presently underneath scientific investigation, and the security and efficacy in these circumstances haven’t been absolutely evaluated by any regulatory authority.
U.S. INDICATIONS
DUPIXENT is a prescription medication used:
to deal with adults and kids 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) that isn’t nicely managed with prescription therapies used on the pores and skin (topical), or who can not use topical therapies. DUPIXENT can be utilized with or with out topical corticosteroids. It’s not identified if DUPIXENT is protected and efficient in youngsters with AD underneath 6 months of age.with different bronchial asthma medicines for the upkeep remedy of moderate-to-severe eosinophilic or oral steroid dependent bronchial asthma in adults and kids 6 years of age and older whose bronchial asthma isn’t managed with their present bronchial asthma medicines. DUPIXENT helps stop extreme bronchial asthma assaults (exacerbations) and might enhance your respiration. DUPIXENT can also assist cut back the quantity of oral corticosteroids you want whereas stopping extreme bronchial asthma assaults and enhancing your respiration. It’s not identified if DUPIXENT is protected and efficient in youngsters with bronchial asthma underneath 6 years of age.with different medicines for the upkeep remedy of power rhinosinusitis with nasal polyps (CRSwNP) in adults and kids 12 years of age and older whose illness isn’t managed. It’s not identified if DUPIXENT is protected and efficient in youngsters with CRSwNP underneath 12 years of age.to deal with adults and kids 1 12 months of age and older with eosinophilic esophagitis (EoE), who weigh a minimum of 33 kilos (15 kg). It’s not identified if DUPIXENT is protected and efficient in youngsters with EoE underneath 1 12 months of age, or who weigh lower than 33 kilos (15 kg).to deal with adults with prurigo nodularis (PN). It’s not identified if DUPIXENT is protected and efficient in youngsters with PN underneath 18 years of age.with different medicines for the upkeep remedy of adults with inadequately managed power obstructive pulmonary illness (COPD) and a excessive variety of blood eosinophils (a sort of white blood cell which will contribute to your COPD). DUPIXENT is used to scale back the variety of flare-ups (the worsening of your COPD signs for a number of days) and might enhance your respiration. It’s not identified if DUPIXENT is protected and efficient in youngsters with COPD underneath 18 years of age.to deal with adults and kids 2 years of age and older with power spontaneous urticaria (CSU) who proceed to have hives that aren’t managed with H1 antihistamine remedy. It’s not identified if DUPIXENT is protected and efficient in youngsters with CSU underneath 2 years of age, or who weigh lower than 11 kilos (5 kg).to deal with adults with bullous pemphigoid (BP). It’s not identified if DUPIXENT is protected and efficient in youngsters with BP underneath 18 years of age.to deal with adults and kids 6 years of age and older with allergic fungal rhinosinusitis (AFRS), who’ve had surgical procedure on their nostril or sinuses previously. It’s not identified if DUPIXENT is protected and efficient in youngsters with AFRS underneath 6 years of age.
DUPIXENT isn’t used to alleviate sudden respiration issues and won’t change an inhaled rescue medication or to deal with every other types of hives (urticaria).
IMPORTANT SAFETY INFORMATION
Don’t use in case you are allergic to dupilumab or to any of the substances in DUPIXENT®.
Earlier than utilizing DUPIXENT, inform your healthcare supplier about all of your medical circumstances, together with should you:
have eye issues.have a parasitic (helminth) an infection.are scheduled to obtain any vaccinations. You shouldn’t obtain a “live vaccine” proper earlier than and through remedy with DUPIXENT.are pregnant or plan to turn out to be pregnant. It’s not identified whether or not DUPIXENT will hurt your unborn child. A being pregnant registry for girls who take DUPIXENT throughout being pregnant collects details about the well being of you and your child. are breastfeeding or plan to breastfeed. It’s not identified whether or not DUPIXENT passes into your breast milk.
Inform your healthcare supplier about all of the medicines you’re taking, together with prescription and over-the-counter medicines, nutritional vitamins, and natural dietary supplements.
Particularly inform your healthcare supplier in case you are taking oral, topical, or inhaled corticosteroid medicines; have bronchial asthma and use an bronchial asthma medication; or have AD, CRSwNP, EoE, PN, COPD, CSU, BP, or AFRS and now have bronchial asthma. Don’t change or cease your different medicines, together with corticosteroid medication or different bronchial asthma medication, with out speaking to your healthcare supplier. This will trigger different signs that had been managed by these medicines to return again.
DUPIXENT may cause critical unintended effects, together with:
Allergic reactions. DUPIXENT may cause allergic reactions, together with pores and skin reactions, that may typically be extreme. Cease utilizing DUPIXENT and inform your healthcare supplier or get emergency assist immediately should you get any of the next indicators or signs: respiration issues or wheezing, swelling of the face, lips, mouth, tongue or throat, fainting, dizziness, feeling lightheaded, quick pulse, fever, hives, pores and skin rash, together with rash that appears like a bullseye, painful pink or blue bumps underneath the pores and skin, or pink pus-filled spots on the pores and skin, common in poor health feeling, itching, swollen lymph nodes, nausea or vomiting, joint ache, or cramps in your abdomen space.Eye issues. Inform your healthcare supplier immediately in case you have any new or worsening eye issues, together with eye ache or adjustments in imaginative and prescient, similar to blurred imaginative and prescient. Your healthcare supplier might ship you to an ophthalmologist for an examination if wanted.Irritation of your blood vessels. Hardly ever, this could occur in individuals with bronchial asthma who obtain DUPIXENT. This will occur in individuals who additionally take a steroid medication by mouth that’s being stopped or the dose is being lowered. Inform your healthcare supplier immediately should you get: rash, chest ache, worsening shortness of breath, brown or darkish coloured urine, persistent fever, or a sense of pins and needles or numbness of your arms or legs.Psoriasis. This may occur in individuals with atopic dermatitis and bronchial asthma who obtain DUPIXENT. Inform your healthcare supplier about any new pores and skin signs. Your healthcare supplier might ship you to a dermatologist for an examination if wanted.Joint aches and ache. Some individuals who use DUPIXENT have had hassle strolling or shifting because of their joint signs, and in some circumstances wanted to be hospitalized. Inform your healthcare supplier about any new or worsening joint signs. Your healthcare supplier might cease DUPIXENT should you develop joint signs.
The commonest unintended effects:
Eczema: injection web site reactions; eye issues, together with eye and eyelid irritation, redness, swelling, itching, eye an infection, dry eye, and blurred imaginative and prescient; chilly sores in your mouth or in your lips; and excessive depend of a sure white blood cell (eosinophilia).Bronchial asthma: injection web site reactions; excessive depend of a sure white blood cell (eosinophilia); ache within the throat (oropharyngeal ache); and parasitic (helminth) infections.Persistent Rhinosinusitis with Nasal Polyps: injection web site reactions; eye issues, together with eye and eyelid irritation, redness, swelling, itching, eye an infection, and blurred imaginative and prescient; excessive depend of a sure white blood cell (eosinophilia), abdomen issues (gastritis); joint ache (arthralgia); hassle sleeping (insomnia); and toothache.Eosinophilic Esophagitis: injection web site reactions; higher respiratory tract infections; chilly sores in your mouth or in your lips; and joint ache (arthralgia).Prurigo Nodularis: eye issues, together with eye and eyelid irritation, redness, swelling, itching, and blurred imaginative and prescient; herpes virus infections; widespread chilly signs (nasopharyngitis); dizziness; muscle ache; and diarrhea.Persistent Obstructive Pulmonary Illness: injection web site reactions; widespread chilly signs (nasopharyngitis); excessive depend of a sure white blood cell (eosinophilia); viral an infection; again ache; irritation contained in the nostril (rhinitis); diarrhea; abdomen issues (gastritis); joint ache (arthralgia); toothache; headache; and urinary tract an infection.Persistent Spontaneous Urticaria: injection web site reactions.Bullous Pemphigoid: joint ache (arthralgia); eye issues, together with eye and eyelid irritation, redness, swelling, itching, and blurred imaginative and prescient; and herpes virus infections.Allergic Fungal Rhinosinusitis: injection web site reactions; eye issues, together with eye and eyelid irritation, redness, swelling, itching, eye an infection, and blurred imaginative and prescient; excessive depend of a sure white blood cell (eosinophilia); abdomen issues (gastritis); joint ache (arthralgia); hassle sleeping (insomnia); and toothache.
Inform your healthcare supplier in case you have any facet impact that bothers you or that doesn’t go away. These are usually not all of the potential unintended effects of DUPIXENT. Name your physician for medical recommendation about unintended effects. You’re inspired to report destructive unintended effects of prescribed drugs to the FDA. Go to www.fda.gov/medwatch, or name 1-800-FDA-1088.
Use DUPIXENT precisely as prescribed by your healthcare supplier. It’s an injection given underneath the pores and skin (subcutaneous injection). Your healthcare supplier will resolve should you or your caregiver can inject DUPIXENT. Don’t attempt to put together and inject DUPIXENT till you or your caregiver have been educated by your healthcare supplier. In youngsters 12 years of age and older, it’s beneficial DUPIXENT be administered by or underneath supervision of an grownup. In youngsters 6 months to lower than 12 years of age, DUPIXENT needs to be given by a caregiver.
Please see accompanying full Prescribing Data together with Affected person Data.
About Regeneron Regeneron (NASDAQ: REGN) is a number one biotechnology firm that invents, develops and commercializes life-transforming medicines for individuals with critical illnesses. Based and led by physician-scientists, our distinctive capability to repeatedly and constantly translate science into medication has led to quite a few authorized remedies and product candidates in growth, most of which had been homegrown in our laboratories. Our medicines and pipeline are designed to assist sufferers with eye illnesses, allergic and inflammatory illnesses, most cancers, cardiovascular and metabolic illnesses, neurological illnesses, hematologic circumstances, infectious illnesses, and uncommon illnesses.
Regeneron pushes the boundaries of scientific discovery and accelerates drug growth utilizing our proprietary applied sciences, similar to VelociSuite, which produces optimized absolutely human antibodies and new lessons of bispecific antibodies. We’re shaping the following frontier of medication with data-powered insights from the Regeneron Genetics Heart® and pioneering genetic medication platforms, enabling us to establish progressive targets and complementary approaches to doubtlessly deal with or remedy illnesses.
For extra info, please go to www.Regeneron.com or comply with Regeneron on LinkedIn, Instagram, Fb or X.
About SanofiSanofi is an R&D pushed, AI-powered biopharma firm dedicated to enhancing individuals’s lives and delivering compelling development. We apply our deep understanding of the immune system to invent medicines and vaccines that deal with and defend thousands and thousands of individuals world wide, with an progressive pipeline that might profit thousands and thousands extra. Our staff is guided by one function: we chase the miracles of science to enhance individuals’s lives; this evokes us to drive progress and ship constructive affect for our individuals and the communities we serve, by addressing probably the most pressing healthcare, environmental, and societal challenges of our time.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.
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