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Dupixent Approved in the US as First and Only Treatment for Adolescents with Chronic Rhinosinusitis with Nasal Polyps

Paris and Tarrytown, N.Y. September 13, 2024. The US 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 FDA approval in CRSwNP from June 2019 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 US, approximately 9,000 adolescents live with inadequately controlled CRSwNP.

Brian Foard
Executive Vice President, Head, Specialty Care at Sanofi
“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. 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.”

George D. Yancopoulos, M.D., Ph.D.
Board Co-Chair, President and Chief Scientific Officer at Regeneron
“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. 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.”

The approval is supported by evidence from two positive pivotal studies in adults with inadequately controlled CRSwNP. In the SINUS-24 and SINUS-52 studies, 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 studies, 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 (≥1%) compared to placebo in SINUS-24 and SINUS-52 (24-week safety pool) were injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.

About Dupixent
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL4) and interleukin-13 (IL13) 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 studies, establishing that IL4 and IL13 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.

Sanofi and Regeneron are committed to helping patients in the US 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.

Dupilumab development program
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical studies involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven in part by type 2 inflammation or other allergic processes in phase 3 studies, 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:

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:

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:

The most common side effects include:

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 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.

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.

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Source: Sanofi

Posted: September 2024

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