Sanofi and Regeneron received FDA approval on November 7, 2025 to pursue a priority‑review supplemental biologics license application for Dupixent (dupilumab) in adults and children six years and older with allergic fungal rhinosinusitis (AFRS). The priority‑review status is intended to shorten the agency’s review period to roughly six months, with a target action date of February 28, 2026.
The decision follows the LIBERTY‑AFRS‑AIMS phase‑3 trial, which enrolled 62 patients—33 treated with Dupixent and 29 with placebo. The study met all primary and secondary endpoints, showing significant reductions in sinus opacification, nasal congestion, and nasal polyp burden. These results were presented at the American College of Allergy, Asthma and Immunology 2025 Annual Scientific Meeting in Orlando, Florida, held from November 6‑10.
AFRS affects an estimated 1.5 million Americans, yet current standard care—surgical debridement followed by systemic steroids—often leads to high recurrence rates and significant morbidity. Dupixent’s mechanism, blocking IL‑4 and IL‑13 signaling, directly targets the type‑2 inflammatory pathway that drives AFRS pathology, offering a non‑surgical therapeutic option. In the trial, common adverse events included mild COVID‑19 infections and epistaxis, consistent with Dupixent’s safety profile in other respiratory indications.
Dupixent’s commercial momentum is evident: in Q3 2025, Sanofi reported €4.2 billion in sales—up 26.2% from €3.5 billion in Q3 2024—while Regeneron posted $4.86 billion in global net sales, a 27% increase over $3.82 billion in Q3 2024. The new AFRS indication would become the ninth FDA‑approved indication for Dupixent, expanding its reach beyond the current eight and reinforcing Sanofi’s strategy to grow its immunology portfolio.
The potential approval also carries strategic implications. A new indication would broaden Dupixent’s patient base, potentially capturing a sizable share of the AFRS market and reducing reliance on the already crowded asthma and atopic dermatitis segments. The FDA’s priority‑review status signals confidence in the data, and the February 28, 2026 target action date aligns with the company’s forecasted growth trajectory. Analysts have noted that the drug’s consistent performance across indications supports a bullish outlook for both Sanofi and Regeneron’s immunology businesses.
The announcement has already attracted attention from investors and industry observers, who view the AFRS approval as a key driver of future revenue growth. While the market has not yet reacted to the specific event, the broader trend of Dupixent’s expanding indications continues to support positive sentiment around the companies’ immunology strategies.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.