Regeneron and Sanofi’s Dupixent (dupilumab) Receives FDA’s Approval for Chronic Rhinosinusitis with Nasal Polyposis

Regeneron and Sanofi’s Dupixent (dupilumab) Receives FDA’s Approval for Chronic Rhinosinusitis with Nasal Polyposis

Shots:

  • The approval is based on two SINUS-24 & SINUS-52 studies results assessing Dupixent (300mg, q2w) + mometasone furoate nasal spray (MFNS) vs PBO + MFNS in patients with CRSwNP with uncontrolled disease
  • The SINUS-24 & 52 studies results: nasal congestion/obstruction improvement (57% & 51% vs 19% & 15%); reduction in nasal polyps score (33% & 27% vs 7% & 4%); improvement in sinus opacification (42% & 27% vs 4% & 0%); improvement in loss of smell (52% & 45% vs 12% & 10%); 83% reduction in surgery; 74% reduction in systemic corticosteroids administration
  • Dupixent (SC) is a mAb inhibiting the signals IL-4 & IL-13 available as pre-filled syringe, approved in EU, Japan & Australia for asthma and is under review in EU for CRSwNP & in Japan & EU for atopic dermatitis

Click here to read full press release/ article | Ref: Regeneron | Image: The Pike Company