The FDA has approved dupilumab (Dupixent, Sanofi and Regeneron Pharmaceuticals) for adults with nasal polyps accompanied by prolonged inflammation of the sinuses and nasal cavity. It is the first treatment to be approved for inadequately controlled chronic rhinosinusitis with nasal polyps, which can lead to loss of smell.
The safety and efficacy of dupilumab were established in two studies involving 724 adults with chronic rhinosinusitis with nasal polyps who were symptomatic with use of intranasal corticosteroids. Patients who received dupilumab had statistically significant reductions in nasal polyp size and nasal congestion compared to patients receiving placebo. Dupilumab patients also reported an improved ability to smell and are less likely to need nasal polyp surgery and fewer oral steroids.
Serious allergic reactions and eye problems can occur with dupilumab, including conjunctivitis and keratitis. The most commonly reported side effects were injection-site reactions and eye/eyelid inflammation, which included redness, swelling, and itching. Also, live vaccines should be avoided for patients taking dupilumab.
Dupilumab was originally approved in 2017 for adult patients with moderate-to-severe atopic dermatitis that is inadequately controlled by topical therapies or when such therapies are inadvisable. In 2018, the drug was approved as add-on maintenance treatment for patients aged 12 and older with moderate-to-severe eosinophilic asthma or oral corticosteroid-dependent asthma. It was also approved in March 2019 for adolescent patients with moderate-to-severe atopic dermatitis that is inadequately controlled by topical therapies.
Source: FDA, June 26, 2019