Sanofi and its partner Regeneron have secured U.S. Food and Drug Administration approval for their biologic Dupixent (dupilumab) as the first and only medicine for allergic fungal rhinosinusitis (AFRS) in patients six years of age and older.
The approval follows a phase‑3 LIBERTY‑AFRS‑AIMS study that enrolled 62 adults and children. Dupixent reduced the risk of requiring systemic corticosteroids or surgery by 92% over 52 weeks compared with placebo, and improved sinus opacification scores by 50% versus 10% for placebo.
This new indication marks Dupixent’s ninth FDA approval and adds a chronic type‑2 inflammatory condition that often requires surgery and long‑term steroids. In Q4 2025, Regeneron reported global Dupixent net sales of $4.9 billion, up 34% year‑over‑year, while Sanofi’s Dupixent sales reached €4.2 billion, a 32.2% increase. The growth reflects strong demand across the drug’s existing indications and the expanded label.
Sanofi’s CEO Paul Hudson noted in January 2026 that Dupixent had reached a new quarterly high in Q4 2025, reinforcing the company’s strategy of leveraging its immunology platform for high‑margin growth. Regeneron’s CEO Leonard Schleifer highlighted Dupixent’s status as the most widely used innovative branded antibody medicine, with over 1.4 million active patients worldwide, underscoring the drug’s commercial momentum.
The approval positions Dupixent as the sole FDA‑approved therapy for AFRS, expanding its addressable market and likely driving future sales growth for both companies. The addition strengthens the company’s portfolio of type‑2 inflammatory disease treatments and supports Sanofi’s broader immunology strategy.
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