Sanofi: FDA approves Dupixent as first biologic medicine for children aged 6 to 11 years with moderate-to-severe atopic dermatitis

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The U.S. FDA approved Dupixent® (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent is the only biologic medicine approved for this patient population.

“This FDA approval is another milestone in the journey for Dupixent as an innovative biologic treatment for atopic dermatitis and other conditions driven in part by type 2 inflammation,” said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. “Caregivers of children with moderate-to-severe atopic dermatitis and their physicians now have access to a first-in-class biologic with a proven safety profile, a factor that often plays a critical role in treatment decisions for younger patients. Additionally, improvements in itch and disease severity were observed as early as two weeks after the first dose and continued throughout active treatment, which is important for these children and their families.”

Dupixent is a fully-human monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, and is not an immunosuppressant. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). Across all approved indications globally, more than 150,000 patients have been treated with Dupixent.

“This approval brings the paradigm-changing efficacy and established safety profile of Dupixent to children with moderate-to-severe atopic dermatitis. This young, vulnerable population struggles with debilitating symptoms and disease covering over half of their body, impacting them and their families, who spend countless hours helping them manage their disease,” said George D. Yancopoulos, M.D., Ph.D., Co-founder, President and Chief Scientific Officer at Regeneron. “We continue to study Dupixent in even younger children with uncontrolled moderate-to-severe atopic dermatitis from 6 months to 5 years old, as well as in children with uncontrolled, persistent asthma. Additionally, we are investigating Dupixent in other diseases driven by type 2 inflammation including eosinophilic esophagitis, food and environmental allergies, chronic obstructive pulmonary disease and other dermatologic diseases.”

Dupixent continues to revolutionize the treatment of moderate-to-severe atopic dermatitis

The FDA evaluated the Dupixent application under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions. The FDA previously granted Breakthrough Therapy designation to Dupixent for the treatment of severe atopic dermatitis in children 6 months to 11 years of age not well controlled on topical prescription medications. The Breakthrough Therapy designation was created to expedite the development and review of drugs developed for serious or life-threatening conditions.

Atopic dermatitis, the most common form of eczema, is a chronic inflammatory disease that often appears 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 or darkness, crusting and oozing. Itch is one of the most burdensome symptoms for patients and can be debilitating.

Dupixent comes in two doses, prescribed based on weight (300 mg every four weeks for children ≥15 to <30 kg and 200 mg every two weeks for children ≥30 to <60 kg, following an initial loading dose), as a pre-filled syringe for pediatric patients aged 6 to 11 years.

About Regeneron

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 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, pain, infectious diseases and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

About Sanofi

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.