Sanofi said it will pursue global regulatory submissions for amlitelimab in atopic dermatitis despite mixed Phase 3 results. One pivotal study met primary and key secondary endpoints, while a second trial yielded outcomes that met U.S. statistical criteria but missed the European analysis thresholds, largely due to differing handling of rescue‑medication non‑responders. Sanofi framed its filing strategy on the “totality of data,” noting consistent vIGA‑AD responses under the U.S. analysis and convenience advantages for the dosing regimen. Analysts warned the mixed dataset and an isolated safety signal could complicate European filings and payor positioning; Sanofi still views amlitelimab as a potential Dupixent successor if regulators accept its global analyses.