PARIS (dpa-AFX) - Sanofi (SNY, SAN.PA) said FDA has approved Dupixent or dupilumab for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis who have a history of sino-nasal surgery. The FDA evaluated Dupixent under priority review for the treatment of AFRS. The company said the approval expands approved indications in sino-nasal diseases to now include AFRS, alongside chronic rhinosinusitis with nasal polyps. The FDA approval is supported by the LIBERTY-AFRS-AIMS phase 3 study.
George Yancopoulos, President and Chief Scientific Officer at Regeneron, said: 'This ninth FDA approval for Dupixent, the most widely used innovative branded antibody medicine, strengthens the established efficacy and body of evidence that IL4 and IL13 are major drivers of type 2 inflammation across many chronic diseases.'
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.
At last close, shares of Sanofi were trading at 80.61 euros, down 0.19%.
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