- Results from the Phase 3 CAFÉ study assessing Regeneron Pharmaceuticals (REGN +1%) and Sanofi (PA:SASY)'s (SNY +0.6%) Dupixent (dupilumab) in adults with moderate-to-severe atopic dermatitis who are inadequately controlled with or are intolerant to cyclosporine A (CSA) showed a significant treatment benefit. The data are being presented at the EADV Congress in Geneva.
- Patients receiving weekly or bi-weekly Dupixent and topical corticosteroids (TCS) experienced an average improvement in symptoms from baseline of 78% and 80%, respectively, compared to 47% for those treated with placebo and TCS.
- The proportion of patients achieving at least a 75% improvement in symptoms (EASI-75) was 59% and 63%, respectively, in the weekly/bi-weekly Dupixenet cohorts versus 30% for placebo + TCS.
- No new safety signals were observed.
- CSA is approved in most European countries and Japan to treat atopic dermatitis, but not in the U.S.
- The FDA approved Dupixent for the indication in March. The European Commission should OK it shortly. The advisory committee CHMP adopted a positive opinion backing approval in July.
- Now read: Swoop In To Pick Up Regeneron This Month
Original article