FDA Accepts Resubmission of Dupixent Application for Chronic Spontaneous Urticaria
Key Insights
The FDA has accepted the resubmitted sBLA for Dupixent (dupilumab) for chronic spontaneous urticaria (search) (CSU) treatment in patients aged 12 years and older.
The resubmission includes data from the LIBERTY-CUPID Phase III clinical trial program, specifically Study C, evaluating Dupixent with standard antihistamines.
Study C results showed Dupixent significantly reduced itch severity and urticaria activity compared to placebo in patients uncontrolled on antihistamines.
The FDA has accepted Sanofi and Regeneron's resubmitted supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (search) (CSU) in patients aged 12 years and older whose symptoms are inadequately controlled by H1 antihistamines (search). The target action date for the FDA decision is April 18, 2025.
The resubmitted sBLA is supported by data from the LIBERTY-CUPID Phase III clinical trial program, incorporating results from Study C. This study assessed Dupixent in conjunction with standard-of-care antihistamines in patients with uncontrolled CSU.
LIBERTY-CUPID Study C Details
LIBERTY-CUPID Study C was a randomized, double-blind, placebo-controlled trial involving 151 patients aged six years and older with CSU who remained symptomatic despite antihistamine use and had not previously been treated with Dupixent. The trial compared Dupixent as an add-on to standard-of-care antihistamines against antihistamine monotherapy. The primary endpoint was the change from baseline in itch severity at 24 weeks. Secondary endpoints included changes in itch and hives, the proportion of patients achieving well-controlled disease status, and complete response based on urticaria activity scores.
Efficacy Results
At week 24, patients treated with Dupixent showed an 8.64-point reduction in the weekly itch severity score, compared to a 6.10-point reduction in the placebo group. Furthermore, Dupixent demonstrated a 15.86-point reduction in urticaria from baseline, along with a higher rate of well-controlled disease status and complete response based on urticaria activity scores.
According to Thomas B. Casale, MD, professor at the University of South Florida, the data reinforces Dupixent's potential to alleviate symptoms significantly for patients, helping them better control this challenging disease.
Safety Profile
The safety results from Study C were consistent with the established safety profile of Dupixent in its approved dermatological indications. The rates of treatment-emergent adverse events (AEs) were similar between the Dupixent and placebo groups, both at 53%. Common AEs included injection site reactions, accidental overdoses, and COVID-19 infection.
Background on CSU
CSU affects approximately 1.7 million people in the United States, and roughly 50% of patients do not achieve complete symptom control with antihistamines alone. The condition is characterized by unpredictable episodes of intense itching and hives, significantly impacting daily life. Peak incidence occurs between 20 and 40 years of age, with women affected nearly twice as often as men. CSU can last one to five years in most patients but may persist longer in severe cases. It affects approximately 0.5% to 1% of the global population.
Previous Regulatory Actions
In October 2023, the FDA issued a Complete Response Letter (CRL) for this Dupixent indication, requesting additional efficacy data without raising concerns about safety or manufacturing.