Sanofi is discontinuing the development of amlitelimab as a treatment for atopic dermatitis.
Sanofi has decided to scrap the development of amlitelimab for atopic dermatitis (AD) after the drug failed to show significant improvement over the current standard of care. The French pharmaceutical company determined that the efficacy and safety evidence gathered to date did not justify further investment in the asset. The drug was the centerpiece of a $1.4 billion acquisition of the biotech firm Kymab in 2021. While amlitelimab showed success in reducing skin lesions during Phase 3 trials, it remained inferior to Sanofi’s blockbuster immunology drug, Dupixent. Consequently, the company has canceled plans to submit the drug for FDA approval in the AD category later this year. Sanofi will continue to run a mid-stage trial of amlitelimab for celiac disease, but it has removed several other indications from its pipeline. Despite the discontinuation, the company’s full-year 2026 guidance remains unchanged. A spokesperson stated that the move reflects a commitment to following the science and making tough choices to advance transformative medicines.