CAMBRIDGE, Mass. and TARRYTOWN, N.Y., March 11, 2019 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids.
"For the first time, adolescents with uncontrolled moderate-to-severe atopic dermatitis have an approved biologic treatment option to help control persistent, often debilitating symptoms such as chronic itch and widespread rash. Today's approval expands the use of Dupixent in the U.S. to include both adults and adolescents with atopic dermatitis or moderate-to-severe asthma," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "Given that Dupixent targets a key pathway in type 2 inflammation, we are also investigating it in a broad development program in patients with other type 2 inflammatory diseases including eosinophilic esophagitis, chronic rhinosinusitis with nasal polyps, where we recently announced positive Phase 3 results and Priority Review of a U.S. regulatory submission, and food and environmental allergies."
Dupixent is a targeted biologic therapy that inhibits signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that may play a central role in type 2 inflammation that underlies atopic dermatitis and several other allergic diseases.
"The approval of Dupixent for adolescents with moderate-to-severe atopic dermatitis means that for the first time these patients and their families, who often help them manage this debilitating disease, will have access to a first-of-its-kind biologic treatment that has already been used to treat approximately 50,000 patients in the U.S.," said John Reed, M.D., Ph.D., Head of Research and Development at Sanofi. "Our Phase 3 data demonstrated that Dupixent treatment significantly improved skin lesions, reduced itching, and helped clear the skin of these adolescent patients."
The FDA evaluated the Dupixent application under Priority Review, which is reserved for medicines that represent potentially significant improvements in safety or efficacy in treating serious conditions. Dupixent was also granted Breakthrough Therapy designation by the FDA for inadequately controlled moderate-to-severe atopic dermatitis in adolescents. The Breakthrough Therapy designation was created to expedite the development and review of drugs developed for serious or life-threatening conditions.
Dupixent helped clear the skin and reduced itching in adolescents living with uncontrolled moderate to severe atopic dermatitis
In the pivotal Phase 3 trial evaluating Dupixent monotherapy in adolescent patients with uncontrolled moderate-to-severe atopic dermatitis, the safety and efficacy were generally consistent with that previously seen in adult studies. At 16 weeks:
- The average improvement in the Eczema Area and Severity Index (EASI) from baseline was approximately 66% compared to 24% for placebo
- More than 10 times as many patients had clear or almost clear skin with Dupixent compared to placebo: 24% of patients who received Dupixent achieved clear or almost clear skin compared to 2% with placebo, as measured by an Investigator's Global Assessment (IGA) score of 0 or 1, the primary endpoint of the trial
- Over five times as many patients saw overall disease improvement of at least 75% with Dupixent compared to placebo: 42% of patients who received Dupixent achieved 75% or greater skin improvement compared to 8% with placebo, as measured by EASI-75
- Over seven times as many patients experienced significantly reduced itch with Dupixent compared to placebo: 37% of patients who received Dupixent achieved a clinically meaningful improvement in itch of at least four points on the Peak Pruritus Numerical Rating Scale (NRS) compared to 5% with placebo
Dupixent has been studied in more than 7,000 patients 12 years and older in over 30 clinical trials. The safety profile of Dupixent in the adolescent trial was similar to the safety profile from trials in adults with atopic dermatitis, and consistent through 52 weeks. The most common adverse events were injection-site reactions, eye and eyelid inflammation including redness, swelling and itching, pain in the throat (oropharyngeal pain) and cold sores in the mouth or on the lips.
Atopic dermatitis, a form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin. Moderate-to-severe atopic dermatitis is characterized by rashes that can potentially cover much of the body, and can include intense, persistent itching, skin lesions and skin dryness, cracking, redness, crusting and oozing. Itch is one of the most burdensome symptoms for patients and can be debilitating.
Dupixent comes in two doses (200 mg and 300 mg), each as a pre-filled syringe. Dupixent is intended for injection under the skin (subcutaneous injection) and is given every other week following an initial loading dose. It can be given in a clinic or, for convenience, at home by self-administration after training by a healthcare professional.
Dupixent is also approved in the U.S. for the treatment of adult patients with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies; and for use with other asthma medicines for the maintenance treatment of moderate-to-severe asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines. In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of moderate-to-severe (adolescents 12 to 17 years of age) and severe (children 6 months to 11 years of age) atopic dermatitis not well controlled on topical prescription medications.
Sanofi and Regeneron 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.
Outside of the U.S., Dupixent is also approved in a number of other countries for use in certain adults with moderate-to-severe atopic dermatitis. Dupixent is currently under regulatory review for adolescents with moderate-to-severe atopic dermatitis in several countries, including Japan, and in the European Union (EU).
Dupilumab is being developed jointly by Sanofi and Regeneron as part of a global collaboration agreement.
Dupilumab Development Program
In addition to the currently approved indications, Sanofi and Regeneron are also studying dupilumab in a broad range of clinical development programs for diseases driven by allergic and other type 2 inflammation, including chronic rhinosinusitis with nasal polyps (Phase 3 completed), pediatric (6 to 11 years of age) atopic dermatitis (Phase 3), pediatric (6 months to 5 years of age) atopic dermatitis (Phase 2/3), pediatric (6 to 11 years of age) asthma (Phase 3), eosinophilic esophagitis (Phase 2/3), and food and environmental allergies (Phase 2). A future trial is planned for chronic obstructive pulmonary disease. Dupilumab is also being studied in combination with REGN3500, which targets IL-33. These potential uses are investigational and the safety and efficacy have not been evaluated by any regulatory authority.
Dupixent is a prescription medicine used:
- to treat people 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) 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 12 years of age.
- with other asthma medicines for the maintenance treatment of moderate-to-severe asthma in people aged 12 years 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 12 years of age.
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all 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, neuromuscular diseases, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
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Posted: March 2019
- FDA Approves Dupixent (dupilumab) for Moderate-to-Severe Asthma – October 19, 2018
- FDA Approves Dupixent (dupilumab) for Eczema – March 28, 2017
- Sanofi and Regeneron Announce Dupilumab Biologics License Application Accepted for Priority Review by U.S. FDA – September 26, 2016
Dupixent (dupilumab) FDA Approval History
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