FDA Approves New Option for Chronic Rhinosinusitis With Nasal Polyps
The US Food and Drug Administration has approved dupilumab (dupixent), the first treatment option for chronic, inadequately controlled rhinosinusitis with nasal polyps.
The safety and efficacy of the injection were evaluated in 2 studies involving 724 patients with chronic rhinosinusitis and nasal polyps whose symptoms remained despite treatment with intranasal corticosteroids. Those patients who were given dupilumab saw statistically significant reductions in nasal polyp size and nasal congestion compared to those given placebo. They also reported increased ability to smell.
The drug was originally approved in 2017 for the treatment of eczema in patients aged 12 years and older. In 2018, it was approved for the treatment of moderate-to-severe eosinophilic asthma or oral corticosteroid-dependent asthma in patients aged 12 years and older.
Potential serious allergic reactions and eye problems, including conjunctivitis or keratitis, could occur with treatment with dupilumab. The most common side effects include injection site reactions and eye and eyelid inflammation.
FDA approves first treatment for chronic rhinosinusitis with nasal polyps [press release]. June 26, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-chronic-rhinosinusitis-nasal-polyps