The U.S. Food and Drug Administration has approved Dupixent, made by Sanofi and Regeneron Pharmaceuticals Inc., for children aged 2 to 11 with a chronic skin condition, making it the first biologic medicine available for this group.
"With this approval, Dupixent has become the first biologic medicine in the U.S. for young children suffering from uncontrolled chronic spontaneous urticaria, an unpredictable skin disease that impacts quality of life during these children’s most formative years,” said George D. Yancopoulos, board co-chair, president and chief scientific officer at Regeneron.
The approval for chronic spontaneous urticaria (CSU) was based on data from the LIBERTY-CUPID clinical trial program. Efficacy and safety data were extrapolated from studies in patients aged 12 and older, supported by a Phase 3 study in 2 to 11-year-olds which primarily assessed pharmacokinetics. In the studies on older patients, Dupixent significantly reduced itch and hives compared to a placebo after 24 weeks.
This marks the ninth approval for Dupixent in allergy-related conditions and its fifth indication for children under 12. The expanded approval targets more than 14,000 children in the U.S. whose CSU is not adequately controlled with standard H1-antihistamine treatment, opening a new market for the blockbuster drug.
Chronic spontaneous urticaria is an inflammatory skin disease characterized by the sudden and debilitating appearance of hives and recurring itch. The disease is driven in part by type 2 inflammation, which Dupixent targets by inhibiting the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13).
The safety profile for children aged 2 to 11 was consistent with Dupixent's known profile in other approved indications. The most common adverse reaction observed in trials was injection site reactions. The treatment is administered as a subcutaneous injection every two or four weeks, depending on the child's age and weight.
The expanded approval strengthens Dupixent's position as a leading multi-indication biologic. For investors, this decision represents a meaningful expansion of the drug's addressable market, potentially adding to its multi-billion dollar annual sales. The next catalyst will be the companies' upcoming earnings reports, where analysts will look for commentary on the launch and uptake in this new pediatric population.
This article is for informational purposes only and does not constitute investment advice.
