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.
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