FDA Approves Sanofi and Regeneron's Dupilumab for Urticaria

Sanofi and Regeneron have achieved a significant milestone with the US Food and Drug Administration's (FDA) recent approval of their monoclonal antibody, Dupixent (dupilumab), for addressing chronic spontaneous urticaria (CSU) in individuals aged 12 years and older. This new approval targets patients whose symptoms persist despite treatment with histamine-1 (H1) antihistamines.

The FDA's decision was based on robust data from Phase III clinical trials, namely Study A and Study C. These trials focused on biologic-naïve patients aged 12 and above who continued to exhibit symptoms despite antihistamine therapy. Dupixent was evaluated as an additional treatment alongside antihistamines. Both trials successfully met their primary and key secondary endpoints, revealing significant reductions in itch and urticaria severity at the 24-week mark when compared to a placebo.

Further insights came from Study B, which provided additional safety data and evaluated Dupixent in patients over 12 years old who had insufficient response or tolerance to anti-immunoglobulin E (IgE) therapy while remaining symptomatic despite antihistamine treatment. The safety results across all three studies aligned with the known safety profile of Dupixent in its various approved uses.

Alyssa Johnsen, head of Sanofi Immunology and Oncology Development's Global Therapeutic Area, emphasized the impact of CSU on patients, noting that those with uncontrolled symptoms endure significant discomfort, which can disrupt daily activities. She stated that this FDA approval introduces a new therapeutic option aimed at addressing the root causes of these severe and recurrent symptoms.

Globally, Dupixent has already received approval for treating CSU in countries like the United Arab Emirates, Brazil, and Japan. Additionally, it is under review by regulatory authorities in the European Union and other regions. As a chronic inflammatory skin disorder, CSU is partly driven by type 2 inflammation, which results in recurring itching and severe hives. The development of Dupixent has shown to reduce type 2 inflammation in Phase III trials.

The creation of Dupixent is the result of a worldwide partnership between Sanofi and Regeneron. It was developed using Regeneron's VelocImmune technology. Beyond CSU, Dupixent has garnered regulatory approvals in over 60 countries for a range of conditions, including asthma, prurigo nodularis, chronic rhinosinusitis with nasal polyps, atopic dermatitis, chronic obstructive pulmonary disease, and eosinophilic esophagitis. This broad spectrum of approvals underscores the versatility and effectiveness of Dupixent as a therapeutic agent in tackling various inflammatory diseases.