Regeneron and Sanofi‘s Dupixent shows treatment benefit in adolescents with atopic dermatitis

Regeneron Pharmaceuticals (NASDAQ:) and development partner Sanofi (NYSE:) detailed results from a Phase 3 clinical trial evaluating Dupixent (dupilumab) in adolescents (ages 12 – 17 years) with moderate-to-severe atopic dermatitis (AD). The data were presented at the EADV Congress in Paris.

The co-primary endpoint ex-U.S. was the proportion of patients achieving EASI-75 (75% improvement in symptoms) while the primary endpoint in the U.S. was the proportion of patients achieving IGA 0 (clear skin) or 1 (almost clear).

41.5% of patients receiving Dupixent every two weeks and 38% of those receiving the drug every four weeks achieved EASI-75 compared to 8% for placebo (p<0.001).

24% of patients receiving weight-based dosing of Dupixent every two weeks and 18% of those receiving a fixed-dose regimen every four weeks achieved IGA 0 or 1 compared to 2% for placebo (p<0.001).

Key secondary endpoints were also met.

On the safety front, adverse events (AEs) were observed in 72% of patients in two-week group, 64% in the four-week group and 69% for control. The most frequent AEs were injection site reactions (8.5%, 6% and 3.5%, respectively).

The results will support global marketing applications.

Dupixent was approved in the U.S. in March 2017 and in Europe six months later for adults with moderate-to-severe AD. It is also approved in Japan and Canada.

Previously: (May 16)

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