FDA Accepts Resubmitted sBLA for Dupilumab Treatment of Chronic Spontaneous Urticaria

An announcement was made by Regeneron Pharmaceuticals, Inc. and Sanofi that their resubmission of a supplemental Biologics License Application (sBLA) for dupilumab (Dupixent) was accepted by the US Food and Drug Administration (FDA) for treating chronic spontaneous urticaria (CSU).¹

The treatment is indicated for adults and adolescents aged 12 and older who’s CSU has been inadequately managed with H1 antihistamines. The resubmission of the sBLA is supported by data drawn from the LIBERTY-CUPID phase 3 clinical program, which included 3 studies (Study A, Study B, and Study C) assessing dupilumab in those with CSU.

“The positive pivotal data from this study reinforce the potential of [dupilumab] to offer a new treatment option for the many people suffering from chronic spontaneous urticaria who do not respond to standard-of-care antihistamines," Dietmar Berger, MD, PhD, chief medical officer and global head of Development at Sanofi, said in a statement. "With clinically meaningful reductions in itch and hives for patients receiving [dupilumab], we look forward to sharing these data with the FDA to bring [dupilumab] to patients with CSU in the US as soon as possible.”²

CSU is a chronic inflammatory condition impacting the skin and characterized by sudden outbreaks of hives and persistent itching. Although H1 antihistamines are commonly implemented with the aim of symptom alleviation by targeting H1 receptors, many users do not achieve sufficient levels of relief.

In the US, around 300,000 individuals are known to struggle with CSU which is not being effectively controlled by the antihistamines. Dupilumab is a fully human monoclonal antibody which was designed to block IL-4 and IL-13 signaling pathways, key drivers of type 2 inflammation.

Dupilumab, unlike immunosuppressants, has demonstrated significant clinical benefits, such as type 2 inflammation reduction. The therapy is approved in more than 60 countries for different indications such as asthma, atopic dermatitis, and chronic rhinosinusitis with nasal polyps.

Dupilumab’s sBLA resubmission was supported by data resulting from the phase 3 LIBERTY-CUPID clinical program, including Study A, Study B, and Study C, the latter of which is the most recent addition. Study C involved subjects whose CSU was uncontrolled despite antihistamine utilization and it confirmed earlier findings by demonstrating significant hive and itch activity reductions.¹

Safety outcomes were also highlighted across the trials, with findings aligning with the drug’s previously-established safety profile. The investigators had noted common side effects including injection site reactions and COVID-19 infections.

Dupilumab has already been given approval for CSU in the United Arab Emirates and Japan. It is currently undergoing regulatory review in the European Union. A decision on the therapy option by the FDA is anticipated by April 18, 2025.

References

1. ^{Dupixent® (dupilumab) sBLA Accepted for FDA Review for the Treatment of Chronic Spontaneous Urticaria (CSU). Regeneron Pharmaceuticals. November 15, 2024. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-sbla-accepted-fda-review-treatment-chronic.}
2. ^{Sanofi. Press release: Dupixent phase 3 study confirms significant improvements in itch and hives for patients with CSU. Sanofi. September 11, 2024. Accessed September 15, 2024. https://www.sanofi.com/en/media-room/press-releases/2024/2024-09-11-05-05-00-2944239.}