Medication Monitor

Generic Name (Trade Name—Company)
June 27, 2019


FDA approves first treatment for chronic rhinosinusitis with nasal polyps

FDA approved dupilumab, given by injection, as the first treatment for adults with nasal polyps accompanied by inadequately controlled chronic rhinosinusitis. 

Efficacy and safety of dupilumab were established in two studies with 724 patients, aged 18 years and older, with chronic rhinosinusitis with nasal polyps who were symptomatic despite taking I.N. corticosteroids. Patients who received dupilumab had statistically significant reductions in their nasal polyp size and nasal congestion compared with the placebo group. Patients taking dupilumab also reported an increased ability to smell and required less nasal polyp surgery and oral steroids.

The agent may cause serious allergic reactions and eye problems, such as conjunctivitis and keratitis. If patients experience new or worsening eye symptoms, such as redness, itching, pain, or visual changes, they should consult their health professional. The most common adverse effects reported include injection site reactions as well as eye and eyelid inflammation, which included redness, swelling, and itching. Patients receiving dupilumab should avoid receiving live vaccines.

Dupilumab was originally approved in 2017 for patients aged 12 years and older with eczema that is not controlled adequately by topical therapies or when those therapies are not advisable. In 2018, the agent was approved as add-on maintenance treatment for patients aged 12 years and older with moderate to severe eosinophilic asthma or with oral corticosteroid-dependent asthma.