> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Sanofi Dermatitis Drug Meets Endpoints in Study
- URL: https://www.fdaweb.com/sanofi-dermatitis-drug-meets-endpoints-in-study/
- Published: 2025-09-04T12:00:00.000Z
- Updated: 2026-09-14T15:20:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159816

Sanofi says its investigational antibody amlitelimab met all primary and key secondary endpoints in a late-stage trial of patients with moderate-to-severe atopic dermatitis, reinforcing its potential as a first-in-class therapy with dosing as infrequent as four times a year. In the global COAST 1 Phase 3 trial, Sanofy says amlitelimab, given every four weeks or every 12 weeks, achieved statistically significant improvements in skin clearance and disease severity compared with placebo at Week 24\. The drug also demonstrated steadily increasing efficacy over the treatment period, it says, adding that key secondary goals — including reductions in pruritus (itch) and erythema (skin redness) — were also met.

“These positive first Phase 3 results of amlitelimab reinforce the potential of targeting the OX40-ligand to normalize the overactive immune system, without depleting T cells,” a Sanofi’ release says. “Amlitelimab may represent a significant advance in the treatment of atopic dermatitis … with the potential of dosing only four times per year.”