Sanofi (NASDAQ: SNY), the French pharmaceutical giant, has announced the presentation of new data from the Phase III LIBERTY-CUPID Study C for its drug Dupixent (dupilumab) in the treatment of chronic spontaneous urticaria (CSU) at the American College of Allergy, Asthma and Immunology (ACAAI) 2024 annual meeting. The LIBERTY-CUPID Study C focuses on evaluating the efficacy and safety of Dupixent in biologic-naive patients with uncontrolled CSU who are undergoing background therapy with antihistamines.
A total of 151 children and adult subjects were enrolled in the study, which randomized them to receive either Dupixent (n=74) or a placebo (n=77) in addition to standard-of-care histamine-1 (H1) antihistamines. After 24 weeks, Dupixent showed significant improvements over placebo in terms of itch severity score (8.64- vs. 6.10-point reduction from baseline; p=0.02), urticaria activity score (15.86- vs. 11.21-point reduction from baseline; p=0.02), and complete response rate (urticaria activity score=0; 30% vs. 18%; p=0.02). The safety profile of Dupixent was found to be generally consistent with previous studies.
Dupixent (dupilumab), a fully human monoclonal antibody that inhibits the signaling of the IL4 and IL13 pathways, is not an immunosuppressant. It was originated by Regeneron Pharmaceuticals and is commercialized by Sanofi globally. The drug is registered in over 60 countries, with indications covering a range of conditions including atopic dermatitis, asthma, chronic sinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), nodular prurigo, CSU, and chronic obstructive pulmonary disease (COPD). Dupixent has also received approval for CSU in Japan and the United Arab Emirates (UAE), and it is currently under regulatory review in the European Union based on earlier trial results.- Flcube.com
