Press Release: Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria

FDA Review and Dupixent's Potential in CSU - The FDA has accepted the resubmission of the supplemental biologics license application (sBLA) for Dupixent to treat chronic spontaneous urticaria (CSU) in adults and pediatric patients aged 12 years and older who are inadequately controlled by H1 antihistamines [1] - The target action date for the FDA decision is April 18, 2025, and if approved, Dupixent would be the first targeted therapy for CSU in a decade [1] - The resubmitted sBLA includes new pivotal data from Study C of the LIBERTY-CUPID phase 3 clinical program, which confirmed Dupixent significantly reduced itch and hive activity in patients with uncontrolled CSU [2] Clinical Data and Safety Profile - Study C, part of the LIBERTY-CUPID phase 3 program, met its primary and key secondary endpoints, showing Dupixent's efficacy in reducing itch and urticaria activity [2] - Safety results across all LIBERTY-CUPID phase 3 studies were consistent with Dupixent's known safety profile, with injection site reactions and COVID-19 infection being the most common adverse events (≥5%) compared to placebo [3] Market and Regulatory Landscape - More than 300,000 people in the US suffer from CSU that is inadequately controlled by antihistamines, highlighting a significant unmet medical need [4] - Dupixent has already been approved for CSU in Japan and the United Arab Emirates and is under regulatory review in the EU [6] - Globally, more than 1,000,000 patients are currently being treated with Dupixent across various indications, including atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps [8] Dupixent's Mechanism and Development - Dupixent is a fully human monoclonal antibody that inhibits the signaling of the IL4 and IL13 pathways, which are key drivers of type-2 inflammation [7] - The Dupilumab development program, a collaboration between Sanofi and Regeneron, has studied over 10,000 patients across more than 60 clinical trials for various chronic diseases driven by type-2 inflammation [9] - Dupilumab is also being investigated in phase 3 studies for other conditions, such as chronic pruritus of unknown origin and bullous pemphigoid [10] Company Overview - Regeneron is a leading biotechnology company focused on developing life-transforming medicines for serious diseases, with a strong pipeline in allergic and inflammatory diseases, cancer, and rare diseases [11] - Sanofi is a global healthcare company dedicated to improving lives through innovative treatments and vaccines, with a focus on sustainability and social responsibility [14]