Sanofi announced Friday it will not seek regulatory approval for amlitelimab in atopic dermatitis, ending development of the eczema drug as new chief executive Belen Garijo conducts a broad review of the company's pipeline.
The French drugmaker said the drug would not represent a meaningful improvement over existing treatments, including its own Dupixent
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Sanofi announced Friday it will not seek regulatory approval for amlitelimab in atopic dermatitis, ending development of the eczema drug as new chief executive Belen Garijo conducts a broad review of the company's pipeline.
"The totality of efficacy and safety evidence generated to date does not support further development of amlitelimab in AD," Sanofi said in a statement. The drug "would not represent a meaningful improvement to the standard of care for patients," the company added.
The decision marks a significant retreat for a drug Sanofi had, as recently as March, said showed potential to be a meaningful treatment option, according to the Wall Street Journal. Some analysts had noted that amlitelimab's efficacy did not match that of Dupixent, Sanofi's top-selling product, which it developed jointly with Regeneron $REGN Pharmaceuticals.
Sanofi acquired amlitelimab as part of its $1.1 billion purchase of Kymab in 2021, according to Fierce Biotech. The drug had struggled in late-stage testing: September 2025 data from a phase 3 trial disappointed Wall Street, and a second phase 3 readout in January cleared its primary endpoint but stumbled on secondary measures. Even so, Sanofi had at that point pledged to pursue regulatory submissions using the aggregate clinical evidence.
The reversal came after Garijo replaced Paul Hudson as CEO. Hudson's exit was driven in part by a series of clinical setbacks that included amlitelimab, according to Fierce Biotech. Garijo subsequently replaced research-and-development chief Houman Ashrafian with former Roche executive Paulo Fontoura.
Data from the phase 3 ESTUARY long-term extension study indicated that patients aged 12 and older sustained their clinical responses without relapsing, and that the drug's safety profile continued to develop, Sanofi said. Results from the ESTUARY study and other amlitelimab atopic dermatitis trials will be presented at a future medical meeting, the company said.
Amlitelimab's development in other conditions is not entirely over. A midstage study of the drug in celiac disease remains ongoing, with results expected in the second half of 2026, the company said.
Sanofi said the decision leaves its full-year 2026 financial guidance intact. The company is scheduled to report second-quarter earnings next week.
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