FDA Approves Sanofi/Regeneron's Dupixent for Chronic Spontaneous Urticaria

Sanofi and Regeneron have announced that their medication, Dupixent (dupilumab), has received approval from the US Food and Drug Administration (FDA) to treat chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 and above. This approval targets individuals whose symptoms persist despite treatment with histamine-1 (H1) antihistamines.

The FDA's decision was significantly influenced by the outcomes of two advanced-stage clinical trials. These trials assessed Dupixent as an additional treatment to standard H1 antihistamines, comparing its effects with those of antihistamines alone. The studies successfully reached their main and secondary objectives, showing that Dupixent effectively decreased itch severity and urticaria activity relative to a placebo over a 24-week period. Furthermore, patients receiving Dupixent had a higher probability of achieving well-controlled disease or a complete response compared to those on placebo.

Chronic spontaneous urticaria (CSU) is a persistent condition identified by red, swollen, itchy, and sometimes painful hives or wheals that persist for six weeks or more. The standard treatment involves H1 antihistamines, but over 300,000 individuals in the United States suffer from CSU that these medications do not adequately control.

Dupixent is a fully human monoclonal antibody that works by inhibiting the signaling of the interleukin-4 and interleukin-13 pathways. These pathways are critical in driving type 2 inflammation, which contributes to several related conditions, including CSU. Administered via a subcutaneous injection, Dupixent stands out as the first new targeted therapy for CSU to be approved by the FDA in more than a decade.

Alyssa Johnsen, who leads the global therapeutic area in immunology and oncology development at Sanofi, emphasized the significance of this approval. She noted that CSU patients with uncontrolled symptoms often face severe itch and hives, which can greatly disrupt daily life. This FDA endorsement introduces a novel treatment option aimed at addressing the underlying causes of these severe and recurring symptoms.

In addition to its new indication for CSU, Dupixent is approved in the United States for treating several other conditions. These include certain forms of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease. George Yancopoulos, co-chair of the board, president, and chief scientific officer at Regeneron, and a leading inventor of Dupixent, remarked on the significance of this FDA decision. He highlighted that Dupixent is now approved for seven chronic, debilitating atopic conditions linked to underlying type 2 inflammation. Many of these conditions often co-occur with CSU, providing patients with a single treatment option that may address multiple atopic conditions.

This recent FDA approval underscores the ongoing advancements in targeted therapies that address specific inflammatory pathways, offering hope to patients with chronic conditions previously lacking effective treatment options. As Dupixent expands its indications, it continues to play a crucial role in managing various inflammatory diseases, further cementing its place in the therapeutic landscape.