FDA Approves Dupixent for Chronic Spontaneous Urticaria
- The U.S. Food and Drug Administration approved Dupixent for chronic spontaneous urticaria in adults and adolescents 12 and older on April 18, 2025.
- This approval was based on data from two Phase 3 clinical studies involving patients who remained symptomatic despite standard antihistamine treatment.
- The trials assessed Dupixent as an add-on therapy in biologic-naïve patients aged 12 years and older.
- Both studies met primary endpoints, demonstrating reductions in itch severity and increased likelihood of well-controlled disease at 24 weeks.
- The clearance provides a new treatment option for over 300,000 eligible U.S. Patients and represents Dupixent's seventh FDA-approved indication.
28 Articles
28 Articles

FDA Approves Dupixent for Chronic Spontaneous Urticaria
WEDNESDAY, April 23, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of adults and adolescents with chronic spontaneous urticaria.
Sanofi-Regeneron’s Dupixent gets FDA’s nod for skin condition
(Reuters) -The U.S. Food and Drug Administration approved the use of Sanofi and Regeneron’s blockbuster drug Dupixent for patients with a type of skin condition, the two companies said on Friday. The agency’s green light is a victory for the companies, as the FDA had declined to approve the drug for the skin condition in 2023 and had sought more efficacy data. Dupixent is now cleared with allergy medication for patients aged 12 years and older w…
FDA Approves New Option for Chronic Hives
(MedPage Today) -- The FDA approved dupilumab (Dupixent) for chronic spontaneous urticaria (CSU) in patients 12 years and older, the first new targeted drug for the inflammatory skin disease in over a decade, drugmakers Regeneron and Sanofi announced...
Dupixent Makes History with FDA Approval as First New CSU Treatment in Over a Decade
The U.S. Food and Drug Administration (FDA) approved Sanofi’s dupilumab (Dupixent) for the treatment of chronic spontaneous urticaria (CSU) in patients aged 12 and older … Dupixent Makes History with FDA Approval as First New CSU Treatment in Over a Decade Read More » The post Dupixent Makes History with FDA Approval as First New CSU Treatment in Over a Decade first appeared on GeneOnline News. The post Dupixent Makes History with FDA Approval a…
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