Regeneron and Sanofi Report the US FDA’s sBLA Acceptance of Dupixent (Dupilumab) to Treat Chronic Spontaneous Urticaria (CSU)
Shots:
- The US FDA has accepted the resubmitted sBLA of Dupixent to treat CSU patients (≥12yrs.), inadequately controlled with H1 antihistamine treatment, based on the data from Study C of P-III (LIBERTY-CUPID) trial. Decision is expected on Apr 18, 2025
- The LIBERTY-CUPID program included 3 studies, Studies A, B & C, with Studies A & C involving patients with uncontrolled CSU on antihistamines, while Study B focused on those uncontrolled on antihistamines & refractory or intolerant to omalizumab
- Study C achieved its 1EP & confirmed results from Study A, showing significantly reduced itch & hives as well as a safety similar to its known profile, with injection site reactions & COVID-19 being the most common AEs (≥5%)
Ref: Regeneron | Image: Regeneron & Sanofi
Related News:- Sanofi and Regeneron Reports the EC’s Approval of Dupixent (Dupilumab) for Young Children with Eosinophilic Esophagitis (EoE)
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
