Dupixent Approved by European Commission as First and Only Biologic Medicine for Children Aged 6 to 11 Years with Severe AD

Dupixent is the only systemic medicine approved in the EU to treat these patients.

The European Commission (EC) has given its nod to Dupixent (dupilumab) for children 6 to 11 with severe atopic dermatitis who are candidates for systemic therapy. 

Dupixent is the only systemic medicine approved in the EU to treat these patients.

"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," says Korey Capozza, MPH, Founder and Executive Director of Global Parents for Eczema Research (GPER), in a news release. "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."

"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," says George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer at Regeneron. "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).

"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," adds John Reed, MD, PhD, Global Head of Research and Development at Sanofi. "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 percent and 61 percent for Dupixent every four and two weeks, respectively, and 73 percent and 75 percent 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).

About the Pediatric Trial

The co-primary endpoints in the pediatric trial were skin clearance, as measured by a score of 0 or 1 on the Investigator's Global Assessment (IGA), and disease extent and severity, as measured by Eczema Area and Severity Index score (EASI-75).

Secondary endpoints included the average change in EASI score from baseline, and itch as measured by at least a 4-point reduction in itch intensity on a 0 to 10-point scale (weekly average of daily Peak Pruritus Numerical Rating Scale). Additionally, HR-QoL was measured by the proportion of patients who achieved at least six points on the patient-reported Children's Dermatology Life Quality Index (CDLQI), as well as additional measures from Patient Oriented Eczema Measure (POEM) and SCORing Atopic Dermatitis (SCORAD).