The US FDA Approves Regeneron and Sanofi’s Dupixent for Allergic Fungal Rhinosinusitis (AFRS)
Shots:
- FDA approved Dupixent for pts (≥6yrs.) with AFRS & have a history of sino-nasal surgery, based on the P-III (LIBERTY-AFRS-AIMS) trial, assessing age & weight-based Dupixent dosing (200 or 300mg; Q2W or Q4W; n=33) vs PBO (n=29) in 62 pts
- Trial met its 1EP with improved sinus opacification by 50% vs 10% at Wk. 52, with significant reduction at Wk. 24. Patient-reported nasal congestion improved by 67% vs 25% at Wk. 24 & 81% vs 11% at Wk. 52
- Polyp size reduced by 61% vs 15% at Wk. 24 & 63% vs 4% at Wk. 52; loss of smell decreased by 67% vs 19% at Wk. 24. Over 52wks., Dupixent reduced steroid use/surgery risk by 92% (29% fewer pts); 3% & 0% received steroids or surgery vs 31% & 7% on PBO
Ref: Sanofi | Image: Sanofi & Regeneron | Press Release
Related News: Sanofi Reports P-III (LEAP2MONO) Trial Data on Venglustat in Type 3 Gaucher Disease
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com


