Dupixent approved in EU for infants, young children with severe atopic dermatitis
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Key takeaways:
- Dupixent was approved in the European Union to treat severe atopic dermatitis in children aged 6 months to 5 years.
- The approval was supported by positive results from a phase 3 trial.
The European Commission approved Dupixent in the European Union for the treatment of severe atopic dermatitis in infants and young children who are candidates for systemic therapy, Sanofi and Regeneron announced in a press release.
Dupixent (dupilumab) is now the first targeted medicine in the EU for patients with severe atopic dermatitis between the ages of 6 months and 5 years.
The approval follows the European Medicines Agency’s recommendation for expanded approval in January and is supported by results from a phase 3 trial in which seven times as many patients between 6 months and 5 years who received Dupixent experienced clear or almost clear skin and reduced overall disease severity compared with those who received placebo (14% vs. 2% and 55% vs. 10%, respectively).
In addition, 75% or greater improvement in overall disease severity was achieved by 46% of patients treated with Dupixent compared with 7% of patients treated with placebo.
Safety results in this young age group were consistent with Dupixent’s known safety profile.
“Dupixent is currently being used to treat more than 600,000 patients around the word across approved indications,” George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron, said in the release. “This latest EU approval brings the proven efficacy and, importantly, the long-term safety profile of Dupixent to this particularly vulnerable population.”
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