Sanofi announced that Dupixent (dupilumab) was approved for the treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in United States by the Food and Drug Administration (FDA). This is the third indication approved for Dupixent along with moderate-to-severe atopic dermatitis, and moderate-to-severe asthma.
As per the company, Dupixent is the only approved medicine indicated for CRSwNP.
The approval is based on two two Phase 3 trials, the 24-week SINUS-24 and 52-week SINUS-52. In the trials, Dupixent was compared with standard of care mometasone furoate nasal spray. Nasal congestion/obstruction severity was observed to be 57% and 51% compared to 19% and 15% on placebo arm. Nasal poly drop scores reduced by 33% and 27% compared to 7% and 4% increase in placebo arm. In terms of secondary endpoints, sinus opacification improved by 42% and 27% compared to 4% and 0% in placebo arm. Smell reduced by 52% and 45% compared to 12% and 10% in patients on placebo arm.
FDA has evaluated Dupixent under priority review.