June 26, 2019
The US Food and Drug Administration (FDA) has approved a drug for the treatment of chronic rhinosinusitis, a prolonged inflammation of the sinuses and nasal cavity, with nasal polyps, growths on the inner lining of the sinuses, in adults.
Dupixent (dupilumab; Regeneron Pharmaceuticals and Sanofi), which is administered by injection, is the first treatment approved by the FDA for inadequately controlled chronic rhinosinusitis with nasal polyps.
"Dupixent is the first FDA-approved medicine for adults with chronic rhinosinusitis with nasal polyposis, and the only approved therapy shown to shrink nasal polyp size and also improve the signs and symptoms of the associated chronic rhinosinusitis. In fact, approximately three-quarters of patients treated with Dupixent no longer required either corticosteroids or surgery, the current standards of care," George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron, said in a statement.
The approval was based on the results of two studies (the 24-week SINUS-24 and 52-week SINUS-52). Together, the studies included 724 patients, 18 years and older, with chronic rhinosinusitis with nasal polyps who were symptomatic despite taking intranasal corticosteroids. According to the study findings, patients that received Dupixent experienced significant reductions in their nasal polyp size and nasal congestion. Additionally, patients also reported an increased ability to smell and required less nasal polyp surgery and oral steroids after receiving Dupixent.
The most commonly reported side effects include injection site reactions (6% Dupixent, 4% placebo), conjunctivitis (2% Dupixent, 1% placebo), arthralgia (3% Dupixent, 2% placebo), and gastritis (2% Dupixent, 1% placebo). According to the FDA, patients that experience new or worsening eye symptoms should consult a health care professional. Additionally, patients receiving Dupixent should avoid receiving live vaccines.
“Nasal polyps can lead to loss of smell and often patients require surgery to remove the polyps,” Sally Seymour, MD, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, said in a 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.”
Since 2017, Dupixent has been approved for the treatment of eczema in patients 12 years and older. Additionally, in 2018, the drug was approved as an add-on maintenance treatment for patients 12 years and older with moderate-to-severe eosinophilic asthma or with oral corticosteroid-dependent asthma.
- Regeneron Pharmaceuticals. FDA APPROVES DUPIXENT® (DUPILUMAB) FOR CHRONIC RHINOSINUSITIS WITH NASAL POLYPOSIS [press release]. https://newsroom.regeneron.com/news-releases/news-release-details/fda-approves-dupixentr-dupilumab-chronic-rhinosinusitis-nasal. June 26, 2019.
- US Food and Drug Administration. FDA approves first treatment for chronic rhinosinusitis with nasal polyps [press release]. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-chronic-rhinosinusitis-nasal-polyps. June 26, 2019.