Sanofi drops amlitelimab filing plans for atopic dermatitis

The French drugmaker said efficacy and safety data gathered so far do not support further development of the eczema treatment as it reviews its pipeline under a new chief executive.

Summary

Sanofi said it will not seek regulatory approval for amlitelimab in atopic dermatitis after deciding that efficacy and safety data generated to date do not support further development of the eczema drug. The French pharmaceutical company said the move comes as it reviews its pipeline following the appointment of a new chief executive. Sanofi had previously said it would discontinue clinical development of amlitelimab in moderate-to-severe atopic dermatitis and would not submit the treatment for global regulatory reviews, despite long-term extension data showing maintenance of clinical response without relapse in patients aged 12 years and older and a safety profile consistent with prior findings. The company has said the drug would not represent a meaningful improvement over the current standard of care, while a phase 2 celiac disease study remains on track for a second-half 2026 readout.

Terms & Concepts
  • Atopic dermatitis: A chronic inflammatory skin condition commonly known as eczema.
  • Regulatory approval: Formal authorization from health authorities to market a drug for a specific use.
  • Phase 2 study: A mid-stage clinical trial that tests a treatment's effectiveness and safety in patients.