FDA Widens Use of Dupilumab to Children With AD as Young as 6 Months

The FDA this week expanded the use of dupilumab for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis (AD) whose disease is not controlled with topical prescription therapies or when those treatments can't be used.

The FDA this week approved dupilumab (Dupixent) for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis (AD).

The biologic, which came on the US market in 2017, is already approved for AD in patients aged 6 and older, as well as for a number of other type 2 inflammatory atopic diseases. Most patients with AD begin showing symptoms before the age of 5, according to a statement from Sanofi.

Sanofi and Regeneron said they are also pursuing approval for this age group with the European Medicines Agency and in additional countries.

Approval was based on phase 3 data evaluating dupilumab every 4 weeks (200 mg or 300 mg, based on body weight) plus low-potency topical corticosteroids (TCS) or TCS alone (placebo). The trial met the primary and all secondary endpoints.

At 16 weeks, patients who received dupilumab with TCS, compared with TCS alone, achieved the following results:

  • 28% had clear or almost-clear skin compared with 4% with placebo, the primary endpoint.
  • 53% had 75% or greater improvement in overall disease severity from baseline compared with 11% with placebo TCS alone, the co-primary endpoint outside of the United States
  • 48% achieved clinically meaningful reduction in itch compared with 9% with placebo.

The safety profile of dupilumab observed through 16 weeks in this young population was similar to the safety profile in patients 6 years and older.

In addition, through 52 weeks, the long-term safety profile of dupilumab in children aged 6 months to 5 years was also similar to what was observed in the pivotal trial and consistent with what was seen in older patients with AD. Hand-foot-and-mouth disease and skin papilloma were, respectively, reported in 5% and 2% of patients on dupilumab aged 6 months to 5 years, and none of these cases led to treatment discontinuation.


Dupilumab is also approved for chronic rhinosinusitis with nasal polyposis AND ASTHMA. Last month, it became the first approved treatment for eosinophilic esophagitis, and the FDA recently accepted it for priority review for the treatment of prurigo nodularis.