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Feb 24, 2026 4:00 PM

Regeneron, Sanofi Blockbuster Dupixent Scores FDA Nod For Rare Sinus Condition

The U.S. Food and Drug Administration on Tuesday approved Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi SA (NASDAQ:SNY) partnered Dupixent (dupilumab) for treating allergic fungal rhinosinusitis (AFRS).

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AFRS is a condition characterized by allergic hypersensitivity to fungi, which often leads to chronic sinus issues and surgery.

The approval covers Dupixent for patients aged six years and older with a history of sino-nasal surgery.

The approval is based on Phase 3 trial results that demonstrated Dupixent’s effectiveness in reducing nasal symptoms and the need for systemic corticosteroids or surgery ...