Dupixent® (dupilumab) sBLA Accepted for FDA Review for the Treatment of Chronic Spontaneous Urticaria (CSU)
Portfolio Pulse from
Regeneron Pharmaceuticals and Sanofi announced that the FDA has accepted the resubmission of the sBLA for Dupixent to treat chronic spontaneous urticaria (CSU). If approved, it would be the first targeted therapy for CSU in a decade, with a decision expected by April 18, 2025.
November 15, 2024 | 6:15 am
News sentiment analysis
Sort by:
Descending
POSITIVE IMPACT
Regeneron's Dupixent sBLA for CSU has been accepted by the FDA, with a decision expected by April 18, 2025. Approval could make it the first targeted therapy for CSU in a decade.
The acceptance of the sBLA by the FDA is a positive regulatory step for Regeneron. If approved, Dupixent would address a significant unmet need in CSU treatment, potentially boosting Regeneron's market position and revenues.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 80