Dupixent® (dupilumab) Approved by European Commission as First and Only Biologic Medicine for Children Aged 6 to 11 Years with Severe Atopic Dermatitis

Regeneron Pharmaceuticals and Sanofi today announced that the European Commission (EC) has extended the marketing authorization for Dupixent® (dupilumab) in the European Union (EU) to include children 6 to 11 years of age with severe atopic dermatitis who are candidates for systemic therapy. Dupixent is the only systemic medicine approved in the EU to treat these patients.

Korey Capozza, MPH, Founder and Executive Director of Global Parents for Eczema Research (GPER) Commented "As the parent of a child with atopic dermatitis, and someone who works with families impacted by this condition daily, I've seen first-hand the enormous physical and mental health burden of this disease, and the toll it can take on the entire family, Young children with severe atopic dermatitis currently have few treatment choices and significant unmet needs. We welcome the addition of new medicines for these underserved patients."

Atopic dermatitis is a chronic inflammatory disease of the skin that can be debilitating, and severe disease can significantly impact many aspects of life for both children and their families. The current standard of care for children with severe atopic dermatitis in Europe is limited to topical treatments, leaving those with poorly-controlled disease to cope with intense, unrelenting itch and skin lesions that can cover much of the body, resulting in skin cracking, redness or darkening, crusting and oozing. In addition, uncontrolled severe atopic dermatitis can have a substantial emotional and psychosocial impact, causing sleep disturbance, symptoms of anxiety and depression and feelings of isolation in children.

George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron Commented "This approval for Dupixent in the EU represents a major advancement for children with severe atopic dermatitis and their families, who spend countless days and nights tending to their child's disease with few treatment options to help alleviate the debilitating symptoms, Dupixent is a novel therapy that addresses a root cause of atopic dermatitis by specifically targeting the underlying type 2 inflammation of the disease. Dupixent has already been used by hundreds of thousands of patients around the world, including those with atopic dermatitis as well as other type 2 inflammatory diseases such as asthma and adults with chronic rhinosinusitis with nasal polyps. We are pleased to bring this paradigm-changing medicine to even younger patients in the EU who need new options beyond steroids or immunosuppressants."

Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, that was invented using Regeneron's proprietary VelocImmune® technology, 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).

John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi Commented "The approval of Dupixent for children in Europe marks another significant milestone for atopic dermatitis patients and their families, broadening the availability of a first-in-class medicine that offers a proven safe and effective treatment for this debilitating skin disease, Dupixent's ability to provide significantly clearer skin, and clinically meaningful reduction of persistent itch, addresses important unmet needs for these children. In addition to atopic dermatitis, we continue to investigate the potential of Dupixent in younger age groups and across a variety of type 2 inflammatory diseases."

In children aged 6 to 11 years weighing 15 to <60 kg, Dupixent 300 mg is administered as an injection under the skin (subcutaneous injection) every four weeks following the initial loading dose given as two injections 14 days apart. For those weighing ≥60 kg, Dupixent 300 mg is administered every two weeks following the initial loading dose given the same day. The dose may be increased to 200 mg every two weeks in patients weighing 15 to <60 kg based on physician's assessment.

The EC decision is based primarily on data that includes pivotal Phase 3 efficacy and safety results of Dupixent combined with topical corticosteroids (TCS) compared to TCS alone (placebo) in children 6 to 11 years with severe atopic dermatitis. At 16 weeks, patients in treatment groups of Dupixent 300 mg every four weeks (N=122) or 200 mg every two weeks (N=59) with TCS experienced:

-- Improved disease extent and severity:

  • 82% average improvement from baseline with Dupixent every four weeks compared to 49% for placebo.
  • 80% average improvement from baseline with Dupixent every two weeks compared to 48% for placebo.
  • 70% of patients in the every four week treatment group achieved at least a 75% improvement compared to 17% for placebo.
  • 75% of patients in the every two week treatment group achieved at least a 75% improvement compared to 26% for placebo.

-- Skin clearance: 

  • 33% of patients achieved clear or almost clear skin with Dupixent every four weeks compared to 11% for placebo.
  • 39% of patients achieved clear or almost clear skin with Dupixent every two weeks compared to 10% for placebo.

-- Reduced itch:

  • 51% of patients achieved clinically significant reduction of itch with Dupixent every four weeks compared to 12% for placebo.
  • 61% of patients achieved clinically significant reduction of itch with Dupixent every two weeks compared to 13% for placebo.
  • A significantly greater proportion of Dupixent patients achieved improvement in itch as early as four weeks.

-- Improved health-related quality of life (HR-QoL):

  • 77% of patients experienced clinically meaningful improvement in patient-reported HR-QoL with Dupixent every four weeks compared to 39% for placebo.
  • 81% of patients experienced clinically meaningful improvement in patient-reported HR-QoL with Dupixent every two weeks compared to 36% for placebo.
  • Dupixent patients also experienced improvements in additional HR-QoL measures assessing disease severity and patient-reported measures such as itch and sleep.

The safety profile of Dupixent in children 6 to 11 years of age followed through week 52, based on an open-label extension trial, was similar to the safety profile observed at week 16 and consistent with the safety profile seen in adults and adolescents with atopic dermatitis. Overall rates of adverse events (AEs) were 65% and 61% for Dupixent every four and two weeks, respectively, and 73% and 75% for placebo. AEs that were more commonly observed with Dupixent included upper respiratory tract infections (11% and 9% for Dupixent every four and two weeks, 10% and 12% for placebo), injection site reactions (10% and 14% for Dupixent every four and two weeks, 6% and 5% for placebo), nasopharyngitis (13% and 3% for Dupixent every four and two weeks, 7% and 10% for placebo), conjunctivitis (7% and 9% for Dupixent every four and two weeks, 4% and 5% for placebo), and fever (3% for both Dupixent groups, 2% and 0% for placebo). Additional prespecified AEs included skin infections (6% and 9% for Dupixent every four and two weeks, 13% for both placebo groups), and herpes viral infections (2% for both Dupixent groups, 5% for both placebo groups).

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