FDA Greenlights Dupilumab for Chronic Spontaneous Urticaria, Marking First Approval in a Decade

Marking the first approval in over a decade for this challenging condition, the FDA has approved dupilumab (Dupixent) to treat chronic spontaneous urticaria in patients 12 and older whose hives and itching remain uncontrolled by antihistamines. | Image Credit: Tada Images - stock.adobe.com

The FDA has expanded the approval of dupilumab (Dupixent) to include patients 12 years and older with chronic spontaneous urticaria (CSU) whose condition is not adequately managed by standard H1 antihistamine treatment.¹

Patients with CSU experience sudden, negatively impairing hives and recurring itch, driven by type 2 inflammation.² Typically, physicians prescribe H1 antihistamines to control symptoms of urticaria, but the disease remains uncontrolled in many patients. Estimates indicate that more than 300,000 individuals living in the US have CSU that is inadequately controlled by antihistamines.

"This FDA approval provides a new treatment option to help address the underlying drivers of these severe and recurring signs and symptoms. Dupixent has the potential to improve outcomes for CSU patients who previously had limited treatment options," Alyssa Johnsen, MD, PhD, global therapeutic area head, immunology and oncology development at Sanofi, stated in a news release.¹

Dupilumab is a fully human monoclonal antibody (mAb) that inhibits the signaling of IL-4 and IL-13 pathways and does not act as an immunosuppressant.² The approval was based on the results from 2 phase 3 clinical studies, study A and LIBERTY-CUPID study C (NCT04180488).¹ Study B provided additional safety evidence on dupilumab through 2 randomized double-blind placebo-controlled phase 3 trials (LIBERTY-CSU CUPID).

Both study A and C met the primary and secondary end points for patients with uncontrolled CSU who received prior therapy with antihistamines, demonstrating reductions in itch severity and urticaria at week 24. These 2 studies assessed patients 6 years and older whereas study B was conducted among patients 12 years and older.

There were 151 children and adults who enrolled in the LIBERTY-CUPID study and received either dupilumab (n = 74) or placebo (n = 77).³ Patients who received dupilumab had an 8.64-point reduction in itch severity from baseline vs a 6.1-point reduction with the placebo (P = .02) at week 24.

Additionally, there was a 15.86-point reduction in urticaria activity severity from baseline with dupilumab vs an 11.21-point reduction with placebo (P = .02). There were 30% of the patients treated with dupilumab who reported complete response compared with 18% of those on the placebo (P = .02). Adverse events (AEs) were more commonly observed with dupilumab (≥ 5%) compared with the placebo, including injection site reactions (12% vs 4%), accidental overdose (7% vs 3%), and COVID-19 infection (8% vs 5%).

Safety results from study A, study B, and study C reflected consistencies, and the most common AE compared with the placebo was injection site reactions (≥ 2%).¹

Dupilumab was previously approved in the US for treatment of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease.⁴

"Dupixent is the first new targeted treatment for chronic spontaneous urticaria, or CSU, in over 10 years, with pivotal trials demonstrating its ability to help patients significantly reduce the hallmark symptoms of intense itch and unpredictable hives associated with this disease," George D. Yancopoulus, MD, PhD, board cochair, president, and chief scientific officer at Regeneron, stated in the news release.

References

1. Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria. News release. Sanofi; April 18, 2025. Accessed April 18, 2025. https://www.sanofi.com/en/media-room/press-releases/2025/2025-04-18-15-15-00-3064131

2. Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria. News release. Sanofi; November 15, 2024. Accessed April 16, 2025. https://www.sec.gov/Archives/edgar/data/1121404/000119312524260686/d793925dex992.htm

3. Dupixent phase 3 study confirms significant improvements in itch and hives for patients with CSU. News release. Sanofi; September 11, 2024. Accessed April 16, 2025. https://www.sanofi.com/en/media-room/press-releases/2024/2024-09-11-05-05-00-2944239

4. Stewart J. Dupixent FDA approval history. Drugs. October 1, 2024. Accessed April 16, 2025. https://www.drugs.com/history/dupixent.html