Regeneron and Sanofi Win FDA Approval for Dupixent in Rare Fungal Sinusitis
FDA has approved Regeneron and Sanofi’s Dupixent for allergic fungal rhinosinusitis in patients aged six and older with a history of sino-nasal surgery. Phase 3 data showed significant nasal symptom reduction and a lower need for systemic corticosteroids or further surgery, marking the ninth type 2 indication.
1. FDA Label Expansion
On February 24, FDA approved Dupixent (dupilumab) for allergic fungal rhinosinusitis (AFRS) in patients aged six years and older who have undergone prior sino-nasal surgery, making it the first and only therapy indicated for this rare chronic sinus condition.
2. Clinical Trial Results
Phase 3 trials demonstrated that Dupixent significantly reduced nasal congestion, discharge and facial pain scores compared with placebo, while also decreasing the reliance on systemic corticosteroids and the need for repeat surgical interventions.
3. Commercial and Financial Implications
This approval extends Dupixent’s label to nine type 2 inflammatory diseases, potentially boosting peak annual sales beyond current estimates; analysts have already raised price targets and shares remain near 52-week highs despite recent short-term resistance.