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News From the Food and Drug Administration
August 6, 2019

Drug Approved for Inflammatory Nasal Cavity Condition

JAMA. 2019;322(5):393. doi:10.1001/jama.2019.11154

An eczema drug is the first medication to receive FDA approval for treating adults who have inadequately controlled chronic rhinosinusitis with nasal polyps.

Dupilumab, which is marketed as Dupixent, was approved in 2017 for patients aged 12 years or older with eczema who can’t use or haven’t gotten adequate relief from topical therapies. A year later, it was approved for patients aged 12 years or older as an add-on maintenance treatment for moderate to severe eosinophilic asthma or oral corticosteroid–dependent asthma.

“Nasal polyps can lead to loss of smell and often patients require surgery to remove the polyps,” Sally Seymour, MD, director of the FDA’s Division of Pulmonary, Allergy, and Rheumatology Products, said in a statement. The recently approved drug, she added, reduces the need for polyp surgery and oral steroids.

Dupilumab is given by injection. Its safety and efficacy were demonstrated in 2 clinical trials involving 724 adults with rhinosinusitis with nasal polyps who had symptoms despite taking intranasal corticosteroids. According to the FDA, patients who received dupilumab had significant reductions in the size of their nasal polyps and in nasal congestion compared with patients in the placebo group. Patients who received dupilumab also said their ability to smell improved and they didn’t need as much nasal polyp surgery or oral steroids.

Common adverse reactions from dupilumab include injection site reactions and eye and eyelid inflammation, including redness, swelling, and itching. The drug also may cause serious allergic reactions and eye problems such as conjunctivitis and keratitis.