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# Sanofi Reports Positive Data for Atopic Dermatitis Drug
- URL: https://www.fdaweb.com/sanofi-reports-positive-data-for-atopic-dermatitis-drug/
- Published: 2026-01-23T12:00:00.000Z
- Updated: 2026-09-14T15:31:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160537

Sanofi says its experimental antibody amlitelimab showed consistent efficacy and a favorable safety profile across multiple late-stage clinical trials in patients with moderate-to-severe atopic dermatitis, paving the way for global regulatory submissions later this year.

In the SHORE Phase 3 trial, amlitelimab met all primary and key secondary endpoints at 24 weeks when used in combination with topical therapies, the company says. Patients receiving the antibody every four weeks or every 12 weeks achieved significantly higher rates of clear or almost clear skin, as measured by the validated Investigator Global Assessment for atopic dermatitis, compared with placebo. Improvements in disease severity, assessed by a 75% or greater reduction in the Eczema Area and Severity Index, were also statistically significant, it says.

Results from the COAST 2 Phase 3 study were more mixed across regions but still met the primary endpoint for the U.S. and U.S.-reference countries, according to the company. In that analysis, amlitelimab monotherapy significantly increased the proportion of patients achieving clear or almost clear skin at 24 weeks versus placebo. However, isays, the drug did not meet all co-primary endpoints in analyses conducted for the European Union and EU-reference countries, limiting formal statistical conclusions for some secondary measures in those regions.

Sanofi says that across both Phase 3 studies, amlitelimab was generally well-tolerated. Rates of treatment-emergent adverse events, serious adverse events, and discontinuations due to adverse events were similar between the amlitelimab and placebo groups. The most commonly reported side effects included nasopharyngitis and upper respiratory tract infections.