FDA approved dupilumab for treatment of chronic spontaneous urticaria

Key takeaways:

• Dupilumab was approved for treatment of chronic spontaneous urticaria in patients aged 12 years and older.
• Several studies reported reduced itch severity and urticaria activity with dupilumab.

The FDA approved dupilumab for the treatment of patients 12 years and older with chronic spontaneous urticaria who remain symptomatic despite histamine-1 antihistamine treatment, according to a company press release.

“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 the 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 comorbidly occur with CSU, such as atopic dermatitis and asthma — providing patients with one treatment that might help multiple atopy conditions.”

Approval of (Dupixent, Regeneron/Sanofi) was based on data from two phase 3 clinical studies that showed dupilumab reduced itch severity and urticaria activity at 24 weeks in patients aged 12 years and older with chronic spontaneous urticaria (CSU) who were symptomatic despite the use of antihistamines. The release also noted dupilumab increased the likelihood of well-controlled disease or complete response at 24 weeks compared with placebo.

A third study provided additional safety data and evaluated dupilumab in patients aged 12 years and older who were inadequate responders or intolerant to anti-IgE therapy and symptomatic despite antihistamine use, according to the release.

Alyssa Johnsen

“CSU patients with uncontrolled disease experience highly burdensome itch and hives that can significantly disrupt daily living,” Alyssa Johnsen, MD, PhD, global therapeutic area head of immunology and oncology development at Sanofi, said in the 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.”