Dupixent® (dupilumab) Approved in the U.S. as First and Only Treatment for Adolescents with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Regeneron Pharmaceuticals and Sanofi announced FDA approval of Dupixent® (dupilumab) for adolescents aged 12-17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). This expands the 2019 approval for adults. The FDA granted Priority Review, recognizing potential significant improvements in treating this serious condition.
CRSwNP affects about 9,000 adolescents in the U.S., causing breathing difficulties and reduced quality of life. Dupixent, as an add-on maintenance treatment, offers an alternative to systemic steroids and surgery, which often result in symptom recurrence.
The approval is based on positive results from two pivotal trials in adults (SINUS-24 and SINUS-52), showing significant improvements in nasal congestion, polyp size, and smell. Safety profile in adolescents is consistent with that observed in adults.
Regeneron Pharmaceuticals e Sanofi hanno annunciato l'approvazione della FDA per Dupixent® (dupilumab) per adolescenti di età compresa tra 12 e 17 anni con rinocinosite cronica con polipi nasali (CRSwNP) non adeguatamente controllata. Questo amplia l'approvazione del 2019 per gli adulti. La FDA ha concesso una Revisione Prioritaria, riconoscendo potenziali miglioramenti significativi nel trattamento di questa grave condizione.
La CRSwNP colpisce circa 9.000 adolescenti negli Stati Uniti, causando difficoltà respiratorie e ridotta qualità della vita. Dupixent, come trattamento di mantenimento aggiuntivo, offre un'alternativa agli steroidi sistemici e alla chirurgia, che spesso portano alla ricomparsa dei sintomi.
L'approvazione si basa su risultati positivi provenienti da due studi pivotal in adulti (SINUS-24 e SINUS-52), che mostrano miglioramenti significativi nella congestione nasale, nella dimensione dei polipi e nell'olfatto. Il profilo di sicurezza negli adolescenti è coerente con quello osservato negli adulti.
Regeneron Pharmaceuticals y Sanofi anunciaron la aprobación de la FDA para Dupixent® (dupilumab) para adolescentes de 12 a 17 años con rinosinusitis crónica con pólipos nasales (CRSwNP) no controlada adecuadamente. Esto amplía la aprobación de 2019 para adultos. La FDA otorgó una Revisión Prioritaria, reconociendo mejoras potenciales significativas en el tratamiento de esta seria condición.
La CRSwNP afecta a aproximadamente 9,000 adolescentes en EE. UU., causando dificultades respiratorias y una calidad de vida reducida. Dupixent, como tratamiento de mantenimiento adicional, ofrece una alternativa a los esteroides sistémicos y la cirugía, que a menudo resultan en la recurrencia de los síntomas.
La aprobación se basa en resultados positivos de dos ensayos cruciales en adultos (SINUS-24 y SINUS-52), que muestran mejoras significativas en la congestión nasal, el tamaño de los pólipos y el olfato. El perfil de seguridad en adolescentes es consistente con el observado en adultos.
레제너론 제약과 생명공학 회사 사노피는 듀픽센트(Dupixent®; 두필루맙)의 FDA 승인을 발표했습니다. 이는 12세에서 17세의 코에서 발생하는 만성 비염과 비강 폴립(CRSwNP)으로 제대로 조절되지 않는 환자에게 해당됩니다. 이는 2019년 성인에 대한 승인을 확장하는 것입니다. FDA는 이 심각한 질환의 치료에 있어 중요한 개선 가능성을 인식하여 우선 검토를 승인하였습니다.
CRSwNP는 미국에서 약 9,000명의 청소년에게 영향을 미쳐 호흡 곤란과 줄어든 생활 질을 초래합니다. 듀픽센트는 보조 치료제로서, 증상 반복을 초래하는 경우가 많은 전신 스테로이드 및 수술의 대안을 제공합니다.
이 승인은 성인 대상 두 개의 중요 임상 시험(SINUS-24 및 SINUS-52)의 긍정적인 결과에 기반하고 있으며, 이는 코 막힘, 폴립 크기 및 후각에서의 중요한 개선을 보여줍니다. 청소년에서의 안전성 프로필은 성인에서 관찰된 것과 일치합니다.
Regeneron Pharmaceuticals et Sanofi ont annoncé l'approbation de la FDA pour Dupixent® (dupilumab) destiné aux adolescents de 12 à 17 ans souffrant de rhinocynusite chronique avec polypes nasaux (CRSwNP) mal contrôlée. Cela étend l'approbation de 2019 pour les adultes. La FDA a accordé un examen prioritaire, reconnaissant le potentiel d'améliorations significatives dans le traitement de cette condition grave.
La CRSwNP affecte environ 9 000 adolescents aux États-Unis, entraînant des difficultés respiratoires et une qualité de vie réduite. Dupixent, en tant que traitement d'entretien complémentaire, offre une alternative aux stéroïdes systémiques et à la chirurgie, qui débouchent souvent sur une récurrence des symptômes.
L'approbation repose sur des résultats positifs de deux essais cliniques pivots chez les adultes (SINUS-24 et SINUS-52), montrant des améliorations significatives de la congestion nasale, de la taille des polypes et de l'odorat. Le profil de sécurité chez les adolescents est cohérent avec celui observé chez les adultes.
Regeneron Pharmaceuticals und Sanofi haben die FDA-Zulassung für Dupixent® (Dupilumab) für Jugendliche im Alter von 12 bis 17 Jahren mit chronischer Rhinosinusitis mit Nasenpolypen (CRSwNP), die nicht ausreichend kontrolliert wird, bekannt gegeben. Damit wird die Genehmigung von 2019 für Erwachsene erweitert. Die FDA hat eine Prioritätsprüfung gewährt und erkennt potenzielle signifikante Verbesserungen bei der Behandlung dieser schweren Erkrankung an.
CRSwNP betrifft etwa 9.000 Jugendliche in den USA und verursacht Atembeschwerden sowie eine verringerte Lebensqualität. Dupixent bietet als ergänzende Erhaltungsbehandlung eine Alternative zu systemischen Steroiden und Operationen, die oft zu einem Rückfall der Symptome führen.
Die Zulassung basiert auf positiven Ergebnissen aus zwei entscheidenden Studien bei Erwachsenen (SINUS-24 und SINUS-52), die signifikante Verbesserungen bei Nasenverstopfung, der Größe von Polypen und dem Geruchssinn zeigen. Das Sicherheitsprofil bei Jugendlichen entspricht dem, das bei Erwachsenen beobachtet wurde.
- FDA approval expands Dupixent's market to adolescents aged 12-17 with CRSwNP
- Priority Review status granted by FDA, indicating potential significant treatment improvements
- Dupixent is the first biologic specifically indicated for adolescents with CRSwNP
- Positive results from SINUS-24 and SINUS-52 trials showing significant improvements in key symptoms
- Dupixent is now treating over one million patients worldwide across multiple diseases
- None.
Insights
The FDA's approval of Dupixent for adolescents with chronic rhinosinusitis with nasal polyps (CRSwNP) is a significant milestone. This expansion to patients aged 12-17 addresses an unmet medical need, as approximately 9,000 adolescents in the U.S. have inadequately controlled CRSwNP. The Priority Review status underscores the treatment's potential impact.
Dupixent's efficacy in reducing nasal congestion, polyp size and improving sense of smell, while decreasing the need for steroids or surgery, is promising. However, it's important to monitor long-term effects in adolescents, as the approval is based on adult trials and pharmacokinetic data. The safety profile appears consistent with known data, but vigilance for adverse events in this younger population is essential.
This FDA approval expands Dupixent's market potential, potentially boosting revenues for Regeneron (NASDAQ: REGN) and Sanofi. With over
Investors should note the expanding indications for Dupixent, now covering multiple age groups and conditions. This diversification reduces risk and enhances the drug's long-term value proposition. However, the relatively small patient population (9,000 adolescents) for this specific indication may limit immediate financial impact. Long-term growth will depend on Dupixent's continued efficacy and safety across its expanding portfolio of indications.
Dupixent's approval for adolescent CRSwNP patients represents a first-in-class treatment for this age group, potentially capturing a niche market. This move aligns with the trend of precision medicine, targeting specific patient populations with unmet needs. The expansion into younger demographics could help build brand loyalty and potentially lead to lifelong patients.
The unmet medical need in this population, coupled with Dupixent's efficacy in reducing systemic steroid use and surgery needs, positions it well for adoption. However, market penetration may face challenges such as insurance coverage for off-label use in children under 12 and competition from established treatments. The drug's success in this new indication could pave the way for further expansions, reinforcing Regeneron and Sanofi's leadership in immunology treatments.
Following Priority Review, Dupixent is now available to patients as young as 12 years with inadequately controlled CRSwNP
Current treatment options leave many patients with uncontrolled disease and often result in the recurrence of nasal polyps
Dupixent is the leading biologic medicine for all five FDA-approved indications in new-to-brand prescriptions
TARRYTOWN, N.Y. and PARIS, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) as an add-on maintenance treatment for adolescent patients aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). This approval expands the initial June 2019 FDA approval in CRSwNP for patients aged 18 years and older. The FDA evaluated Dupixent for this expanded indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.
CRSwNP is a chronic disease of the upper airway, driven in part by type 2 inflammation, that obstructs the sinuses and nasal passages. It can lead to breathing difficulties, nasal congestion and discharge, reduced or loss of sense of smell and taste, facial pressure, sleep disturbance, and overall reduction in quality of life. Though systemic steroids and surgery are the standard treatment for CRSwNP in this age group and can provide relief, many patients may still experience uncontrolled symptoms and the recurrence of nasal polyps. In the U.S., approximately 9,000 adolescents live with inadequately controlled CRSwNP.
“We are pleased to bring the well-established efficacy and safety of Dupixent to the many children suffering from chronic rhinosinusitis with nasal polyps, which can make their breathing more laborious and difficult, and also deprive them of their sense of smell,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent. “More than one million patients around the world are now being treated with Dupixent, from infants to adults, and across multiple diseases exacerbated by type 2 inflammation, from asthma to atopic dermatitis. Today’s approval reinforces our continuing commitment to transforming the treatment paradigms for these types of related diseases.”
“This latest approval for Dupixent marks the first time a biologic is specifically indicated for adolescents with chronic rhinosinusitis with nasal polyps, offering them an option beyond current standard of care,” said Brian Foard, Executive Vice President, Head, Specialty Care at Sanofi. “Dupixent is a cornerstone of our leadership in immunology, and this latest approval supports our continued commitment to chasing the miracles of science for patients with unmet medical needs.”
The approval is supported by evidence from two positive pivotal trials in adults with inadequately controlled CRSwNP. In the SINUS-24 and SINUS-52 trials, Dupixent significantly improved nasal congestion/obstruction severity, nasal polyp size and sense of smell, while also reducing the need for systemic corticosteroids or surgery at 24 weeks compared to placebo. The approval is also supported by pharmacokinetic data from adult and adolescent patients aged 12 years and older with moderate-to-severe asthma and adult patients with inadequately controlled CRSwNP, along with the safety data of Dupixent in adolescents aged 12 years and older with moderate-to-severe asthma.
In the SINUS-24 and SINUS-52 trials, the safety of Dupixent in adults was generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent (≥
About Dupixent
Dupixent, which was invented using Regeneron’s proprietary VelocImmune® technology, 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. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are two of the key and central drivers of type 2 inflammation that play a major role in multiple related and often co-morbid diseases.
Regeneron and Sanofi are committed to helping patients in the U.S. who are prescribed Dupixent gain access to the medicine and receive the support they may need with the DUPIXENT MyWay® program. For more information, please call 1-844-DUPIXENT (1-844-387-4936) or visit www.DUPIXENT.com.
Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, CRSwNP, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease in different age populations. More than 1,000,000 patients are being treated with Dupixent globally.
About Regeneron's VelocImmune® Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial portion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV® (casirivimab and imdevimab), Dupixent, Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz™ (pozelimab-bbfg).
Dupilumab Development Program
Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across more than 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, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven in part by type 2 inflammation or other allergic processes in Phase 3 trials, including chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation and bullous pemphigoid. 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.
U.S. INDICATIONS
DUPIXENT is a prescription medicine used:
- to treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 6 months of age.
- with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in adults and children 6 years of age and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. DUPIXENT is not used to treat sudden breathing problems. It is not known if DUPIXENT is safe and effective in children with asthma under 6 years of age.
- with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults and children 12 years of age and older whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyps under 12 years of age.
- to treat adults and children 1 year of age and older with eosinophilic esophagitis (EoE), who weigh at least 33
pounds (15 kg). It is not known if DUPIXENT is safe and effective in children with eosinophilic esophagitis under 1 year of age, or who weigh less than 33pounds (15 kg). - to treat adults with prurigo nodularis (PN). It is not known if DUPIXENT is safe and effective in children with prurigo nodularis under 18 years of age.
IMPORTANT SAFETY INFORMATION
Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT®.
Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you:
- have eye problems.
- have a parasitic (helminth) infection.
- are scheduled to receive any vaccinations. You should not receive a “live vaccine” right before and during treatment with DUPIXENT.
- are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby.
- A pregnancy registry for women who take DUPIXENT during pregnancy collects information about the health of you and your baby. To enroll or get more information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/
- are breastfeeding or plan to breastfeed. It is not known whether DUPIXENT passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you are taking oral, topical, or inhaled corticosteroid medicines; have asthma and use an asthma medicine; or have atopic dermatitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, or prurigo nodularis and also have asthma. Do not change or stop your corticosteroid medicine or other asthma medicine without talking to your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine or other asthma medicine to come back.
DUPIXENT can cause serious side effects, including:
- Allergic reactions. DUPIXENT can cause allergic reactions that can sometimes be severe. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing, swelling of the face, lips, mouth, tongue or throat, fainting, dizziness, feeling lightheaded, fast pulse, fever, hives, joint pain, general ill feeling, itching, skin rash, swollen lymph nodes, nausea or vomiting, or cramps in your stomach-area.
- Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. Your healthcare provider may send you to an ophthalmologist for an exam if needed.
- Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive DUPIXENT. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by DUPIXENT. Tell your healthcare provider right away if you have: rash, chest pain, worsening shortness of breath, a feeling of pins and needles or numbness of your arms or legs, or persistent fever.
- Joint aches and pain. Some people who use DUPIXENT have had trouble walking or moving due to their joint symptoms, and in some cases needed to be hospitalized. Tell your healthcare provider about any new or worsening joint symptoms. Your healthcare provider may stop DUPIXENT if you develop joint symptoms.
The most common side effects include:
- Eczema: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, dry eye, cold sores in your mouth or on your lips, and high count of a certain white blood cell (eosinophilia).
- Asthma: injection site reactions, high count of a certain white blood cell (eosinophilia), pain in the throat (oropharyngeal pain), and parasitic (helminth) infections.
- Chronic Rhinosinusitis with Nasal Polyps: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, high count of a certain white blood cell (eosinophilia), gastritis, joint pain (arthralgia), trouble sleeping (insomnia), and toothache.
- Eosinophilic Esophagitis: injection site reactions, upper respiratory tract infections, cold sores in your mouth or on your lips, and joint pain (arthralgia).
- Prurigo Nodularis: eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, herpes virus infections, common cold symptoms (nasopharyngitis), dizziness, muscle pain, and diarrhea.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DUPIXENT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.
Use DUPIXENT exactly as prescribed by your healthcare provider. It’s an injection given under the skin (subcutaneous injection). Your healthcare provider will decide if you or your caregiver can inject DUPIXENT. Do not try to prepare and inject DUPIXENT until you or your caregiver have been trained by your healthcare provider. In children 12 years of age and older, it’s recommended DUPIXENT be administered by or under supervision of an adult. In children 6 months to less than 12 years of age, DUPIXENT should be given by a caregiver.
Please see accompanying full Prescribing Information including Patient Information.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.
About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.
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| Regeneron Contacts: Media Relations Anna Hodge Tel: +1 914-255-6475 Anna.Hodge@regeneron.com | Investor Relations Vesna Tosic Tel: +1 914-847-5443 Vesna.Tosic@regeneron.com |
| Sanofi Contacts: Media Relations Sandrine Guendoul Tel: +33 6 25 09 14 25 Sandrine.Guendoul@sanofi.com Evan Berland Tel: +1 215-432-0234 Evan.Berland@sanofi.com Victor Rouault Tel: +33 6 70 93 71 40 Victor.Rouault@sanofi.com Timothy Gilbert Tel: +1 516-521-2929 Timothy.Gilbert@sanofi.com | Investor Relations Thomas Kudsk Larsen Tel: +44 7545 513 693 Thomas.Larsen@sanofi.com Alizé Kaisserian Tel: +33 6 47 04 12 11 Alize.Kaisserian@sanofi.com Arnaud Delepine Tel: +33 6 73 69 36 93 Arnaud.Delepine@sanofi.com Felix Lauscher Tel: +1 908-612-7239 Felix.Lauscher@sanofi.com |
| Keita Browne Tel: +1 781-249-1766 Keita.Browne@sanofi.com Nathalie Pham Tel: +33 7 85 93 30 17 Nathalie.Pham@sanofi.com Tarik Elgoutni Tel: +1 617-710-3587 Tarik.Elgoutni@sanofi.com Thibaud Châtelet Tel: +33 6 80 80 89 90 Thibaud.Chatelet@sanofi.com |
FAQ
What is the new FDA approval for Dupixent (REGN) in September 2024?
How many adolescents in the U.S. are affected by inadequately controlled CRSwNP that Dupixent (REGN) can now treat?
What clinical trials supported the FDA approval of Dupixent (REGN) for adolescents with CRSwNP?
What improvements did Dupixent (REGN) show in the SINUS-24 and SINUS-52 trials for CRSwNP?
