FDA Approves Dupilumab for Treatment of Chronic Spontaneous Urticaria
The approval is based on 2 phase 3 studies demonstrating reductions in itch severity and urticaria activity as a composite of itch and hives at 24 weeks.
The FDA approved dupilumab for the treatment of patients 12 years and older with chronic spontaneous urticaria (CSU) who are symptomatic despite histamine-1 antihistamine treatment.1
The approval is based on 2 phase 3 studies demonstrating reductions in itch severity and urticaria activity as a composite of itch and hives at 24 weeks. | Image Credit: B-design - stock.adobe.com
“CSU patients with uncontrolled disease experience highly burdensome itch and hives that can significantly disrupt daily living,” Alyssa Johnsen, MD, PhD, global therapeutic head of immunology and oncology development at Sanofi, said in a news release.1 “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.”
The approval was based on 2 phase 3 studies, which demonstrated reductions in itch severity and urticaria activity as a composite of itch and hives at 24 weeks. In one study, dupilumab had a 63% reduction in itch severity with the drug compared to 35% with the placebo, equating to a 10.24-point and 6.01-point reduction, respectively. Additionally, there was a 65% reduction in urticaria activity severity compared with 37% for the placebo, equating to a 20.53-point and 12-point reduction, respectively.1,2
In the other study, investigators found that patients had a reduction in itch severity score of 8.64 with dupilumab compared with 6.10 for the placebo. For urticaria activity score, the reductions were 15.86 and 11.21, respectively, and well-controlled disease status was 41% and 23%, respectively. Complete response was 30% and 18%, respectively, according to the data.3
“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 co-chair, president, and chief scientific officer at Regeneron, said in a news release.1 “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.”
Furthermore, safety data was supported by a third study. However, the study did not meet the primary end point as the dupilumab effects were small for patients who were omalizumab-intolerant or incomplete responders. As for safety, the proportion of any treatment-emergent adverse event was similar between dupilumab and the placebo at 57.3% and 56.6%, and the most common included nasopharyngitis, CSU, and injection-site erythema. Severe AEs were reported in 12 patients, equating to 4% in the dupilumab group and 5.7% in the placebo group.4
READ MORE: FDA Updates Resource Center
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