Dupixent notches seventh disease approval with urticaria nod

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Dupixent Receives FDA Approval for Chronic Spontaneous Urticaria, Marking Seventh Disease Indication

Dupixent (dupilumab) has been approved by the FDA in April 2025 as a treatment for chronic spontaneous urticaria (CSU) in adults and adolescents (aged 12 and up) who remain symptomatic despite antihistamine therapy1 2 3 4.
CSU represents the seventh chronic atopic or type 2 inflammation-driven disease for which Dupixent has been approved1 3 4.
The approval was based on phase 3 clinical trial results showing that Dupixent significantly reduced itch and hives compared to placebo in patients with CSU1 4.
Dupixent is the first new targeted therapy approved for CSU in over a decade1 4.
Chronic spontaneous urticaria affects more than 300,000 people in the US who do not achieve relief from current standard antihistamine treatments1.
The expanded indications further establish Dupixent as a key therapy for multiple diseases involving type 2 inflammation, joining previous approvals for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease3.
The approval offers a new treatment option for patients whose CSU symptoms are not controlled by existing medications, providing improved disease control and quality of life1 2.