Sanofi said it will not submit amlitelimab for global regulatory review in moderate-to-severe atopic dermatitis and has discontinued clinical development of the OX40-ligand monoclonal antibody in the disease. The company said the decision followed an ongoing strategic assessment of its pipeline and reflected its view that the totality of efficacy and safety data does not support further development in atopic dermatitis.
Sanofi pointed to the ESTUARY Phase 3 long-term extension study, which showed long-term maintenance of clinical response without relapse in patients ages 12 and older and an emerging safety profile that builds on previous data. Even so, the company said amlitelimab would not represent a meaningful improvement over the current standard of care for patients with atopic dermatitis. Additional results from the development program, including ESTUARY findings, will be presented at a forthcoming medical meeting.
The company said patients with atopic dermatitis still need additional effective treatments because of the disease’s varied immune mechanisms, and Sanofi remains committed to pursuing advances in inflammatory skin conditions. It also said it is grateful to the patients, caregivers, and investigators who supported amlitelimab’s development.
Sanofi will work with investigators, site teams, and regulatory authorities to wind down ongoing amlitelimab atopic dermatitis studies and ensure appropriate transition of care for enrolled patients. The company added that it is not changing its full-year 2026 guidance as a result of the announcement.
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