PARIS (dpa-AFX) - French drug major Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the U.S. Food and Drug Administration has accepted for review the resubmission of the supplemental biologics license application or sBLA for Dupixent (dupilumab) to treat chronic spontaneous urticaria or CSU.
The FDA decision is expected by April 18, 2025. If approved, Dupixent would be the first targeted therapy for CSU in a decade.
The sBLA for Dupixent (dupilumab) is to treat adults and pediatric patients aged 12 years and older with CSU whose disease is not adequately controlled with H1 antihistamine treatment.
CSU is a chronic inflammatory skin disease driven in part by type-2 inflammation, which causes sudden and debilitating hives and recurring itch. The disease is typically treated with H1 antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria, but it remains uncontrolled in many patients.
More than 300,000 people in the US suffer from CSU that is inadequately controlled by antihistamines.
Dupixent, being jointly developed by Sanofi and Regeneron under a global collaboration deal, is a fully human monoclonal antibody that inhibits the signaling of the IL4 and IL13 pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type-2 inflammation in phase 3 studies.
The resubmitted sBLA is supported by data from the multi-study LIBERTY-CUPID phase 3 clinical program (Study A, Study B, and Study C) for Dupixent in CSU, which confirm Dupixent significantly reduced itch and hive activity.
The companies noted that the safety results in all LIBERTY-CUPID phase 3 studies were generally consistent with the known safety profile of Dupixent in its approved indications.
Adverse events more commonly observed with Dupixent were injection site reactions and COVID-19 infection.
Dupixent has been approved for CSU in Japan and the United Arab Emirates and is also under regulatory review in the EU based on earlier study readouts.
Dupixent has received regulatory approvals in more than 60 countries in one or more indications, and more than 1 million patients are currently being treated with Dupixent globally.
Sanofi and Regeneron are also studying dupilumab in a broad range of diseases driven in part by type-2 inflammation or other allergic processes in phase 3 studies.
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