The FDA has approved the monoclonal antibody for patients aged 12 and older who aren’t controlled with antihistamines.
US patients with chronic spontaneous urticaria can now access dupilumab (Dupixent, Regeneron/Sanofi) if they are still symptomatic despite antihistamine treatment.
The FDA approved the subcutaneous injection following promising findings from several studies several studies showing the treatment was safe and effective for patients aged 12 and older.
Two phase 3 studies found that the monoclonal antibody reduced itch and hives at 24 weeks when added to standard-of-care antihistamines compared with antihistamine and placebo treatment. Patients in the treatment group had a loading dose, and then 300mg dupilumab every fortnight, or 200mg if they were paediatric patients under 60kgs.
Urticaria Activity Scores (UAS7) significantly improved in both studies, although only one found a statistically significant improvement in Itch Severity Scores (ISS7). Safety data was consistent with outcomes found in other studies, and the most common adverse event was injection site reactions.
Related
“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,” Dr George Yancopoulus, president and chief scientific officer at Regeneron, told media.
“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.”
