WASHINGTON -- The FDA approved the biologic drug dupilumab (Dupixent) for adults with moderate to severe atopic dermatitis, or eczema, that is not controlled with topical treatments or who need a systemic agent, .
Administered by subcutaneous injection, dupilumab targets the alpha subunit of the interleukin-4 receptor to interrupt the inflammatory chain underlying atopic dermatitis. It's the first such agent to be approved for the condition.
Three placebo-controlled trials with a total of more than 2,100 patients sufficient for approval, the FDA said. These studies demonstrated that dupilumab reduced itch symptoms after 16 weeks, and more patients achieved clear or almost clear skin with the drug versus placebo.
Injection-site reactions, cold sores in and around the mouth, and eye and eyelid inflammation were the most common adverse effects seen with the drug. Some more serious cases of conjunctivitis and keratitis were seen.
Dupilumab has also been studied in pediatric eczema and the drug's manufacturer, Regeneron Pharmaceuticals (co-marketed with Sanofi), is likely to seek approval for that indication as well. But the current approval applies only to adults.
The agent is also under development for asthma, chronic sinusitis, and eosinophilic esophagitis.
Sanofi said the drug would come with a list price of $37,000 per year.