Sanofi and Regeneron Announce Approval of Dupixent® (dupilumab) to Treat Adult Patients with Moderate-to-Severe Atopic Dermatitis in the European Union
- First targeted biologic in the European Union to receive marketing authorization for use in atopic dermatitis -
Paris, France and Tarrytown, New York - September 28, 2017 - Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the European Commission has granted marketing authorization for Dupixent® (dupilumab), for use in adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.
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 often covering much of the body, and can include intense, persistent itching and skin dryness, cracking, redness, crusting, and oozing., Itch is one of the most burdensome symptoms for patients and can be debilitating.7 In addition, people with moderate-to-severe atopic dermatitis experience impaired quality of life, including disrupted sleep, and increased anxiety and depression symptoms along with their disease.
"People with moderate-to-severe atopic dermatitis can experience unbearable symptoms that may significantly impact their quality of life. Many often struggle to control their disease with the treatment options currently available," said Christine Janus, Chief Executive Officer of the International Alliance of Dermatology Patient Organizations. "We support timely access to this important new medication for those with moderate-to-severe atopic dermatitis to help them control and provide relief for this life-altering, often severely debilitating, chronic disease."
Dupixent is a human monoclonal antibody that is designed to specifically inhibit overactive signaling of two key proteins, IL-4 and IL-13, which are believed to be major drivers of the persistent underlying inflammation in atopic dermatitis, and certain other allergic or atopic diseases., Dupixent will come in a pre-filled syringe and can be self-administered by a patient as a subcutaneous injection every other week after an initial loading dose. Dupixent can be used with or without topical corticosteroids.8
"This approval of Dupixent in Europe demonstrates our approach of bringing innovative new therapies to those living with high unmet medical need and today's approval represents an important milestone for people living with moderate-to-severe atopic dermatitis in Europe," said Elias Zerhouni, M.D., President, Global R&D, Sanofi. "Dupixent targets an underlying cause of atopic dermatitis, helps clear the skin, manage the persistent debilitating itch, and improve overall quality of life. We are now focused on quickly making this important new treatment option available to people across Europe who live with this systemic disease."
Following the granting of this marketing authorization, Sanofi and Regeneron will work with relevant local authorities to make Dupixent available to patients in need in countries across Europe.
"Dupixent represents the culmination of decades of our scientific research into the biology of allergic diseases such as moderate-to-severe atopic dermatitis," said George D. Yancopoulos, M.D., Ph.D., President, and Chief Scientific Officer, Regeneron. "We continue to evaluate the potential of dupilumab in the treatment of atopic dermatitis in children and adolescents as well as other allergic inflammatory diseases driven by the IL-4/IL-13 pathway."
Dupixent is approved in the U.S. for the treatment of adults 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.
LIBERTY AD Clinical Program and Results
The approval of Dupixent was based on studies from the global LIBERTY AD clinical trial program, which included nearly 3,000 patients. LIBERTY AD studies including SOLO 1, SOLO 2, CHRONOS, SOLO-CONTINUE and CAFÉ. The studies examined the use of Dupixent either alone (SOLO 1, SOLO 2 and SOLO-CONTINUE) or with topical corticosteroids (CHRONOS or CAFÉ) in moderate-to-severe AD patients who were inadequately controlled with topical prescription therapies or immunosuppresants such as cyclosporine, or for whom those therapies were not advisable.. In all these studies, Dupixent alone or with topical corticosteroids met the primary and key secondary endpoints. The most common adverse events that occurred at a higher rate than placebo in the Dupixent group (> one percent) included injection site reactions, eye and eye lid inflammation including redness, swelling, and itching, and cold sores in the mouth or on the lips.
Dupilumab Program Overview
Dupilumab is currently being evaluated in a comprehensive development program for AD that includes studies in children with severe AD (6 months to 11 years of age) and adolescents with moderate-to-severe AD (12 to 17 years of age). These potential uses are investigational and the safety and efficacy have not been fully evaluated nor confirmed by any regulatory authority.
Dupilumab is also being studied in other inflammatory diseases that are believed to be driven by IL-4/IL-13 pathway, including uncontrolled persistent asthma (Phase 3), nasal polyposis (Phase 3) and eosinophilic esophagitis (Phase 2). These potential uses are investigational and the safety and efficacy have not been fully evaluated by any regulatory authority. Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
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 nearly 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to six FDA-approved treatments and over a dozen product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, and infectious and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through its unique VelociSuite® technologies and ambitious initiatives such as The Regeneron Genetics Center, 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.
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 Schneider et al, AAAI 2013, Practice Parameter Update, page 296
 Eichenfield et al, AAD 2014, Guidelines of Care for Atopic Dermatitis, page 118
 Guideline to treatment, European Dermatology Forum. http://www.euroderm.org/edf/index.php/edf-guidelines/category/5-guidelines-miscellaneous?download=36:guideline-treatment-of-atopic-eczema-atopic-dermatitis. Accessed December 23, 2016
 Gelmetti and Wolleberg, BJD 2014, Atopic dermatitis- all you can do from the outside. Page 19
 National Institutes of Health (NIH). Handout on Health: Atopic Dermatitis (A type of eczema) 2013. http://www.niams.nih.gov/ Health_Info/Atopic_Dermatitis/default.asp. Accessed October 31, 2016.
 Mount Sinai. Patient Care Atopic Dermatitis. Available at: http://www.mountsinai.org/patient-care/health-library/diseases-and-conditions/atopic-dermatitis#risk. Accessed July 2017.
 Zuberbier, T et al. Patient perspectives on the management of atopic dermatitis. J Allergy Clin Immunol vol. 118, pp. 226-232, 2006.
 Dupixent Summary of Product Characteristics.
 Simpson et al. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. NEJM, vol. 375, pp. 2335-2348, 2016.
 Dupixent Prescribing Information 2017. https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf. Accessed July 2017.