Sanofi confirms it will not pursue regulatory submissions for amlitelimab in atopic dermatitis

Sanofi has recently announced the discontinuation of clinical development of amlitelimab, an OX40-ligand monoclonal antibody, in moderate-to-severe atopic dermatitis. The decision to withdraw from global regulatory submissions was reached through an ongoing strategic evaluation of the company’s pipeline.

Having reviewed the full body of efficacy and safety data generated to date, Sanofi concluded that the evidence does not justify continued development of amlitelimab in atopic dermatitis. Although the ESTUARY Phase 3 long-term extension study demonstrated sustained maintenance of clinical response without relapse in patients aged 12 and above with moderate-to-severe atopic dermatitis, alongside a building safety profile consistent with prior data, the therapy was not considered to represent a meaningful step forward relative to the existing standard of care for patients with this condition. Further findings from the amlitelimab atopic dermatitis development programme, including from the ESTUARY study, will be shared at a future medical meeting.

Given the heterogeneous nature of the immune mechanisms underlying atopic dermatitis, patients and their physicians continue to need a broader range of effective treatment options, and Sanofi remains firmly committed to advancing progress in inflammatory skin conditions.

Sanofi extends its sincere gratitude to the patients, caregivers, and investigators who contributed to the development of amlitelimab in atopic dermatitis, including through participation in the ESTUARY study. The company will collaborate closely with investigators, site teams, and regulatory authorities to ensure an orderly wind-down of ongoing amlitelimab atopic dermatitis studies, with appropriate care transitions in place for all enrolled patients.

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Related Topics and Keywords

AMLITELIMAB, atopic dermatitis, Sanofi, Sanofi’s amlitelimab