Press Release: Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria
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The FDA has accepted the resubmission of the supplemental biologics license application for Dupixent to treat chronic spontaneous urticaria. This could make Dupixent the first targeted therapy for CSU in a decade, with a decision expected by April 18, 2025.
November 15, 2024 | 6:15 am
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Regeneron Pharmaceuticals' Dupixent has its sBLA accepted by the FDA for treating chronic spontaneous urticaria. Approval could make it the first targeted therapy for CSU in a decade, potentially expanding its market.
The acceptance of the sBLA for Dupixent by the FDA is a significant regulatory milestone for Regeneron. If approved, Dupixent would be the first targeted therapy for CSU in a decade, potentially increasing its market share and revenue. The decision is expected by April 18, 2025, which could lead to positive investor sentiment in the short term.
CONFIDENCE 95
IMPORTANCE 85
RELEVANCE 90