Sanofi and Regeneron’s Dupixent (dupilumab) has been approved by the US Food and Drug Administration (FDA) for chronic spontaneous urticaria (CSU).
The drug has been authorised to treat the inflammatory skin disease in adults and adolescents aged 12 years and older who remain symptomatic despite histamine-1 (H1) antihistamine treatment.
The FDA’s decision on the drug was supported by results from two late-stage trials, which evaluated Dupixent as an add-on therapy to standard-of-care antihistamines against antihistamines alone.
Both studies achieved their primary and key secondary endpoints, with Dupixent demonstrating reductions in itch severity and urticaria activity compared to placebo at 24 weeks. Sanofi/Regeneron’s drug was also shown to increase the likelihood of well-controlled disease or complete response compared to placebo at 24 weeks.
CSU is a chronic condition characterised by red, raised, itchy and sometimes painful hives or wheals that last for six weeks or longer. The condition is usually treated with H1 antihistamines, however, more than 300,000 people in the US are currently living with CSU that is inadequately controlled by these medicines.
Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 and interleukin-13 pathways, shown in the Dupixent development programme to be central drivers of the type 2 inflammation that plays a major role in multiple related diseases, including CSU.
The drug, which is administered as a subcutaneous injection, is now the first new targeted treatment approved by the FDA for CSU in over ten years, according to the companies.
Alyssa Johnsen, global therapeutic area head, immunology and oncology development at Sanofi, said: “CSU patients with uncontrolled disease experience highly burdensome itch and hives that can significantly disrupt daily living.
“This FDA approval provides a new treatment option to help address the underlying drivers of these severe and recurring signs and symptoms.”
Beyond CSU, Dupixent is approved in the US for certain cases of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic oesophagitis, prurigo nodularis and chronic obstructive pulmonary disease.
George Yancopoulos, board co-chair, president and chief scientific officer at Regeneron, and a principal inventor of Dupixent, said: “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,… providing patients with one treatment that might help multiple atopy conditions.”