Regeneron, Sanofi Get FDA Approval for Dupixent to Treat Chronic Spontaneous Urticaria
Dupixent is the first new targeted therapy to receive FDA-approval for chronic spontaneous urticaria in adults and adolescents over 12 years of age in over a decade.
Image Credit: Adobe Stock Images/doucefleur
The FDA has approved Regeneron’s and Sanofi’s Dupixent (dupilumab) for chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older who remain symptomatic despite treatment with H1 antihistamines. The regulatory action, which marks the first targeted therapy in more than a decade approved by the FDA for CSU, is the seventh approval for Dupixent in chronic atopic diseases driven by type 2 inflammation.1
“Dupixent is the first new targeted treatment for chronic spontaneous urticaria, or CSU, in over ten 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,” said George D. Yancopoulos, MD, PhD, board co-chair, president, chief scientific officer, Regeneron, principal inventor of Dupixent, in a press release. “With this FDA decision, Dupixent is now approved for seven chronic, debilitating atopic conditions driven in part by underlying type 2 inflammation, several of which have been shown to co-morbidly occur with CSU, such as atopic dermatitis and asthma—providing patients with one treatment that might help multiple atopy conditions. We look forward to bringing Dupixent to the more than 300,000 CSU patients in the US with inadequately controlled disease on standard-of-care treatment who, until now, had limited treatment options.”
The FDA based the approval on results from the LIBERTY-CUPID Phase III trial program (Studies A, B, and C).1 The randomized, double-blind, placebo-controlled LIBERTY-CUPID trials evaluated the efficacy and safety of Dupixent as an add-on therapy to standard-of-care antihistamines, compared to antihistamines alone. Studies A and C evaluated patients over six years of age who remained symptomatic despite the use of antihistamines.
Study B included patients over 12 years of age who were symptomatic and who didn’t respond or were intolerant to anti-immunoglobulin E therapy. During the 24-week treatment period, patients in all three trials received 300 mg of Dupixent every two weeks, except for pediatric patients under 132 lbs., who received 200 mg.
The primary endpoint of all three studies was the change from baseline in itch at 24 weeks, measured by the Weekly Itch Severity Score (ISS7). Secondary endpoints included changes from baseline in itch and hives, the proportion of patients achieving well-controlled disease status, and the proportion of patients achieving complete response.1
In Study A, patients treated with Dupixent showed an ISS7 difference of −4.2, with a 95% confidence interval (CI) of −6.6 to −1.8 and a P-value of 0.0005. Additionally, the Urticaria Activity Score over seven days (UAS7) improved by −8.5, with a 95% CI of −13.2 to −3.9 and a P-value of 0.0003. In Study B, UAS7 improved by −5.8, with a 95% CI of −11.4 to −0.3 and a P-value of 0.0390. ISS7 showed a numerical trend toward improvement (−2.9), but this result did not reach statistical significance.
Safety data showed that Dupixent had a similar rate of overall adverse events (AEs) and serious AEs compared to placebo. In the treatment group, 57.3% of patients experienced treatment-emergent AEs (TEAEs) compared to 56.6% in the placebo group. Common TEAEs included nasopharyngitis, CSU, and injection-site erythema.2
“CSU patients with uncontrolled disease experience highly burdensome itch and hives that can significantly disrupt daily living,” said Alyssa Johnsen, MD, PhD, global therapeutic area head, immunology and oncology development, Sanofi, in the press release. “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.”
Dupixent is currently approved for CSU in Japan, Brazil, and the United Arab Emirates, with other regulatory submissions currently under review.1
References
1. Dupixent® (dupilumab) Approved in the U.S. as the First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria (CSU). Regeneron. April 18, 2025. Accessed April 18, 2025. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-approved-us-first-new-targeted-therapy-over
2. Dupilumab in patients with chronic spontaneous urticaria (LIBERTY-CSU CUPID): Two randomized, double-blind, placebo-controlled, phase 3 trials. JACI. Accessed April 18, 2025. https://www.jacionline.org/article/S0091-6749(24)00196-9/fulltext
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