Sanofi and Regeneron Report the US FDA’s Acceptance of sBLA of Dupixent (dupilumab) for Chronic Spontaneous Urticaria in Adults and Adolescents
- The US FDA accepted the sBLA for review of Dupixent to treat adults & adolescents aged ≥12yrs. with CSU not adequately controlled with H1 antihistamine treatment. The US FDA’s decision is expected on Oct 22, 2023
- The sBLA was based on the 2 P-III trials (LIBERTY-CUPID Studies A & B) evaluating Dupixent in 138 & 108 patients aged ≥6yrs. & 12-18yrs. In Study A, Dupixent added to SoC antihistamines nearly doubled the reduction in itch & urticaria activity scores over SoC alone @24wks. in biologic-naïve patients uncontrolled on antihistamines
- In Study B, Dupixent did not reach statistical significance in an interim analysis despite numeric improvements across key EPs & reduction in itch & hives. Dupixent is being studied in P-III (LIBERTY-CINDU CUrIADS program) for CIndU
Ref: GlobeNewswire | Image: Sanofi
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