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The Food and Drug Administration has approved dupilumab (Dupixent) for the treatment of chronic rhinosinusitis accompanied by nasal polyps in adults.
FDA approval is based on results from a pair of studies involving 724 patients aged 18 years or older with chronic rhinosinusitis with nasal polyps who were symptomatic despite undergoing treatment with intranasal corticosteroids and who received either dupilumab or a placebo. Compared with the placebo group, patients receiving dupilumab had statistically significant reductions in nasal polyp size and nasal congestion; they also had an increased ability to smell and required less nasal polyp surgery and oral steroids.
The most commonly reported adverse events were injection-site reactions and eye and eyelid inflammation, which included redness, swelling, and itching. The drug can cause severe allergic reactions and eye problems, such as conjunctivitis or keratitis; patients should also not receive live vaccines while taking dupilumab.
“Nasal polyps can lead to loss of smell, and often patients require surgery to remove the polyps. 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,” said Sally Seymour, MD, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.
Find the full press release on the FDA website.
The Food and Drug Administration has approved dupilumab (Dupixent) for the treatment of chronic rhinosinusitis accompanied by nasal polyps in adults.
FDA approval is based on results from a pair of studies involving 724 patients aged 18 years or older with chronic rhinosinusitis with nasal polyps who were symptomatic despite undergoing treatment with intranasal corticosteroids and who received either dupilumab or a placebo. Compared with the placebo group, patients receiving dupilumab had statistically significant reductions in nasal polyp size and nasal congestion; they also had an increased ability to smell and required less nasal polyp surgery and oral steroids.
The most commonly reported adverse events were injection-site reactions and eye and eyelid inflammation, which included redness, swelling, and itching. The drug can cause severe allergic reactions and eye problems, such as conjunctivitis or keratitis; patients should also not receive live vaccines while taking dupilumab.
“Nasal polyps can lead to loss of smell, and often patients require surgery to remove the polyps. 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,” said Sally Seymour, MD, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.
Find the full press release on the FDA website.
The Food and Drug Administration has approved dupilumab (Dupixent) for the treatment of chronic rhinosinusitis accompanied by nasal polyps in adults.
FDA approval is based on results from a pair of studies involving 724 patients aged 18 years or older with chronic rhinosinusitis with nasal polyps who were symptomatic despite undergoing treatment with intranasal corticosteroids and who received either dupilumab or a placebo. Compared with the placebo group, patients receiving dupilumab had statistically significant reductions in nasal polyp size and nasal congestion; they also had an increased ability to smell and required less nasal polyp surgery and oral steroids.
The most commonly reported adverse events were injection-site reactions and eye and eyelid inflammation, which included redness, swelling, and itching. The drug can cause severe allergic reactions and eye problems, such as conjunctivitis or keratitis; patients should also not receive live vaccines while taking dupilumab.
“Nasal polyps can lead to loss of smell, and often patients require surgery to remove the polyps. 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,” said Sally Seymour, MD, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.
Find the full press release on the FDA website.
