Sanofi drops amlitelimab after phase 3 review
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Sanofi (NASDAQ:SNY) ended amlitelimab’s atopic dermatitis program after reviewing efficacy and safety evidence from its Phase 3 studies.
In January, Sanofi planned submissions after SHORE succeeded, although COAST 2 missed its EU co-primary endpoints.
“The totality of efficacy and safety evidence generated to date does not support further development of amlitelimab in AD,” Sanofi said.
ESTUARY showed maintained responses in patients aged 12 and older, but Sanofi said the drug would not meaningfully improve current care.
Sanofi maintained its 2026 guidance.
Sanofi acquired amlitelimab through its 2021 Kymab purchase, paying about $1.1 billion upfront plus possible $350 million milestones.
A Phase 2 celiac disease study remains ongoing, with results expected during the second half of 2026.
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