FDA Approves Dupixent (Dupilumab) for Chronic Rhinosinusitis

June 26, 2019

First treatment approved for the condition with nasal polyps.

Dupixent (dupilimab, Sanofi and Regeneron) has been approved by the FDA as the first treatment for chronic rhinosinusitis with nasal polyps.

Dupilimab is a interleukin-3 receptor alpha antagonist that was initially approved in 2017 for patients 12 years and older suffering from inadequately controlled atopic dermatitis that couldn’t be controlled with topical therapies. In 2018, its indication was expanded again as an add-on maintenance treatment for patients 12 years and older with moderate-to-severe asthma or oral corticosteroid-dependent asthma. 

The drug’s most recent approval was based upon two studies, SINUS-24 and SINUS-52, which included a total of 724 patients 18 years of age and older that had chronic rhinosinusitis with nasal polyps and were symptomatic despite also taking intranasal corticosteroids. Patients that had received Dupixent had statistically significant reductions in nasal polyp size and nasal congestion compared to the placebo group. 

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“Nasal polyps can lead to loss of smell and often patients require surgery to remove the polyps,” says Sally Seymour, MD, Director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research in an FDA statement. “Dupixent provides an important treatment option for patients whose nasal polyps are not adequately controlled with intranasal steroids. It also reduces the need for nasal polyp surgery and oral steroids.”

300 mg of dupixent should be administered via subcutaneous injection every other week for patients suffering from chronic rhinosinusitis with nasal polyps. 

Dupixent is contraindicated for patients with a known hypersensitivity to dupixent or any of its excipients. 

Helathcare providers should monitor for hypersensitivity reactions including urticaria, rash, erythema nodosum, anaphylaxis, and serum sickness; conjunctivitis and keratitis; eosinophilic conditions including vasculitic rash, worsening pulmonary symptoms, and/or neuropathy, especially upon reduction of oral corticosteroids. Systemic, topical, or inhaled corticosteroids should not be reduced abruptly upon initiation of therapy with Dupixent; however, if reduction is appropriate, it should be conducted gradually. Parasitic (helminth) infections should be treated prior to therapy with Dupixent; therapy should be discontinued if infection occurs while on Dupixent. 

Adverse events reported by patients with chronic rhinosinusitis with nasal polyps include Injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, conjunctivitis. 

 

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