Sanofi Halts Amlitelimab Development in Atopic Dermatitis
Key Takeaways
- Sanofi announced that it will discontinue development of amlitelimab for moderate-to-severe atopic dermatitis (AD) and will not seek global regulatory approval following a strategic pipeline review.
- Although the phase 3 ESTUARY long-term extension study demonstrated sustained disease control and an emerging long-term safety profile, the company concluded the therapy would not offer a meaningful improvement over the current standard of care.
- Sanofi said it remains committed to advancing treatments for inflammatory skin diseases, while development of amlitelimab in celiac disease continues with phase 2 results expected in the second half of 2026.
Sanofi has announced it will discontinue the clinical development of amlitelimab for moderate-to-severe atopic dermatitis (AD), ending plans to submit the investigational therapy for global regulatory review after determining it would not provide a meaningful advance over existing treatment options. The decision follows an ongoing strategic assessment of the company's pipeline.
According to Sanofi, data from the phase 3 ESTUARY long-term extension study showed sustained maintenance of clinical response without relapse in patients aged 12 years and older with moderate-to-severe AD, while also contributing additional long-term safety data. However, after reviewing the totality of efficacy and safety evidence, the company concluded that amlitelimab would not represent a meaningful improvement over the current standard of care for patients with AD. Additional findings from the ESTUARY program are expected to be presented at a future medical meeting.
Sanofi said it will work with investigators, study sites, and regulatory authorities to wind down ongoing AD studies and ensure an appropriate transition of care for enrolled participants. The manufacturer also said the development of amlitelimab outside dermatology will continue.
Source
Sanofi press release. July 24, 2026.