FDA Approves Dupixent® (dupilumab) for Atopic Dermatitis in Children Aged 6 Months to 5 Years

The U.S. Food and Drug Administration (FDA) has granted approval for Dupixent® (dupilumab) to be used in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis (AD). This marks a significant milestone as dupilumab becomes the first biologic medicine available for this age group.

Key Points

  • Dupilumab is now approved for children from infancy to adulthood for treating moderate-to-severe AD.
  • A Phase 3 trial showed that children treated with dupilumab in combination with topical corticosteroids (TCS) achieved clearer skin and significantly reduced itch compared to those treated with TCS alone.
  • Long-term safety data from a 52-week open-label extension trial in this age group reaffirm dupilumab’s established safety profile observed across all other approved age groups.

The Significance

AD is a chronic inflammatory skin disease, with symptoms like persistent itching, skin lesions, dryness, pain, and increased risk of infections. This approval addresses a pressing need, as over 75,000 children aged 5 and under in the U.S. have uncontrolled moderate-to-severe AD.

Expert Insights

Julie Block, President, and CEO of the National Eczema Association, emphasized the importance of this approval in addressing the intense itch and discomfort experienced by young children with AD.

Naimish Patel, Senior VP at Sanofi, noted that this approval provides a crucial treatment option for young patients who have long struggled with the chronic nature of the disease.

George D. Yancopoulos, President, and Chief Scientific Officer of Regeneron, highlighted that dupilumab has transformed AD treatment, offering a well-established safety and efficacy profile for children as young as six months old.

FDA Evaluation

The FDA evaluated dupilumab under Priority Review, given its potential to significantly improve treatment efficacy and safety for this serious condition.

Clinical Trial Results

In a Phase 3 trial, children treated with dupilumab in combination with TCS experienced several positive outcomes compared to those treated with TCS alone:

  • 28% achieved clear or almost-clear skin.
  • 53% achieved a 75% or greater improvement in overall disease severity.
  • 48% achieved a clinically meaningful reduction in itch.

Safety Profile

The safety profile of dupilumabfor children aged 6 months to 5 years was consistent with what was observed in older patients with AD. Hand-foot-and-mouth disease and skin papilloma were reported in a small percentage of Dupixent patients in this age group, with no treatment discontinuations due to these side effects.

About Dupixent®

Dupixent® is administered through subcutaneous injections and is now available for children aged 6 months and older under medical supervision. It has previously been approved for various age groups for conditions like AD, asthma, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis.

Ongoing Research

Sanofi and Regeneron are continuing research on dupilumab for various diseases driven by type 2 inflammation, extending its potential applications beyond the currently approved indications.

This approval of Dupixent® for young children offers new hope and treatment possibilities for those struggling with moderate-to-severe AD from an early age.

Disclaimer: Please note that at the time of publishing this article, Dupixent® is approved for use in children aged 6 years and above in Singapore. Approval for children aged 6 months to 5 years may vary by country, and readers are advised to consult local healthcare authorities or their healthcare providers for the most current information on this medication’s approval status in their region.

AD: atopic dermatitis; FDA: U.S. Food and Drug Administration; TCS: topical corticosteroids

Link to the official press release: https://www.sanofi.com/en/media-room/press-releases/2022/2022-06-07-20-45-00-2458243

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