FDA Accepts Resubmission of Supplemental Biologics License Application for Dupixent for Chronic Spontaneous Urticaria in Patients Under 12

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The FDA has accepted a resubmitted supplemental Biologics License Application (sBLA) for Sanofi and Regeneron’s Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in patients aged 12 years and older who have inadequate control with H1 antihistamines. According to Regeneron, the resubmitted sBLA is supported by data from the LIBERTY-CUPID Phase III clinical trial program, which consisted of studies A, B, and C. The sBLA adds results from Study C, which was conducted in patients with uncontrolled CSU who were on standard-of-care antihistamines.¹

“Chronic spontaneous urticaria is an inflammatory skin condition that affects patients with unpredictable episodes of intense itching and hives, often severely impacting their daily lives. These data confirm results seen in the previous Study A and reinforce the potential of Dupixent to significantly alleviate symptoms for patients, helping them to better control this challenging disease,” said Thomas B. Casale, MD, professor, internal medicine, Morsani College of Medicine at the University of South Florida, in a press release.²

LIBERTY-CUPID Study C was a randomized, double-blind, placebo-controlled clinical trial that evaluated the efficacy and safety of Dupixent as an add-on to standard-of-care antihistamines compared to antihistamine monotherapy in 151 patients aged six years and older with CSU who remained symptomatic despite antihistamine use and who were not previously treated with Dupixent. The primary endpoint of the study was to assess the change from baseline in itch at 24 weeks, with secondary endpoints that included change from baseline in itch and hives, proportion of patients achieving well-controlled disease status, and complete response.

Results found that at week 24, treatment with Dupixent demonstrated an 8.64-point reduction in the weekly itch severity score, compared to a 6.10-point reduction for the placebo group. Additionally, Dupixent demonstrated a 15.86-point reduction in urticaria from baseline, a well-controlled disease status, and a complete response based on urticaria activity scores.

Safety results of Study C were consistent with the known safety profile of Dupixent in its approved dermatological indications Additionally, rates of treatment-emergent adverse events (AEs) were 53% for both Dupixent and placebo. Common AEs included injection site reactions, accidental overdoses, and COVID-19 infection.²

In October 2023, the FDA issued a Complete Response Letter (CRL) to the companies for this indication of Dupixent. According to Sanofi, the CRL stated that additional efficiency data were required, but it did not identify any issues with safety or manufacturing.³

According to the National Library of Medicine, CSU has a peak incidence between 20 and 40 years of age, lasting one to five years in most patients, but longer in severe cases. Women are affected almost twice as often, and it affects anywhere from 0.5% to 1% of the global population. Further, it can occur with angioedema in 30%–50% of patients and should be differentiated from acute urticaria and physically-induced urticaria.⁴

According to Novartis, CSU affects approximately 1.7 million people in the United States. Despite the use of antihistamines, approximately 50% of people do not achieve complete control of their symptoms through treatment. According to a Novartis survey, 70% of CSU patients reported mild to severe anxiety and depression. In another patient-reported survey, one out of five people with CSU reported missing at least one hour of work in the past seven days.⁵

The target action date for the FDA decision for Dupixent as a treatment for CSU is April 18, 2025.¹

References

1. Dupixent® (dupilumab) sBLA Accepted for FDA Review for the Treatment of Chronic Spontaneous Urticaria (CSU). Regeneron. November 15, 2024. Accessed November 15, 2024. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-sbla-accepted-fda-review-treatment-chronic

2. Press Release: Dupixent late-breaking positive phase 3 data in chronic spontaneous urticaria to be presented at ACAAI. Sanofi. October 24, 2024. Accessed November 15, 2024. https://www.sanofi.com/en/media-room/press-releases/2024/2024-10-24-12-00-00-2968628

3. Press Release: Sanofi and Regeneron provide update on Dupixent® (dupilumab) sBLA for Chronic Spontaneous Urticaria. Sanofi. October 20, 2023. Accessed November 15, 2024. https://www.sanofi.com/en/media-room/press-releases/2023/2023-10-20-21-00-00-2764252

4. Chronic spontaneous urticaria. NIH. Accessed November 15, 2024. https://pmc.ncbi.nlm.nih.gov/articles/PMC5235931/#:~:text=Chronic%20spontaneous%20urticaria%20has%20a,but%20longer%20in%20severe%20cases.&text=The%20condition%20affects%200.5%25%E2%80%931,twice%20as%20often%20as%20men.

5. Chronic Spontaneous Urticaria. Novartis. Accessed November 15, 2024. https://www.novartis.com/us-en/patients-and-caregivers/diseases/chronic-spontaneous-urticaria