Sanofi said it will seek regulatory approval for amlitelimab in atopic dermatitis despite mixed Phase III results across trials. The company reported that one pivotal study met primary endpoints under U.S. analyses while another missed certain measures used by European regulators, and a safety study flagged a single case of a skin cancer. Sanofi plans global filings based on the totality of data, positioning amlitelimab as a potential follow‑on to Dupixent with a differentiated dosing profile. Regulators in different jurisdictions applied different responder‑counting rules, producing divergent statistical outcomes; Sanofi’s submission strategy will test whether the U.S. analyses suffice for approval and commercial launch.
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