“This is the first treatment approved for inadequately controlled chronic rhinosinusitis with nasal polyps,” the FDA said in a news release announcing the approval.
Dupilumab is a targeted biologic therapy that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13), which play a central role in type 2 inflammation involved in allergic diseases.
Dupilumab is already approved in the United States for adults and children as young as 12 with moderate-to-severe atopic dermatitis and as add-on maintenance therapy for patients with moderate-to-severe asthma with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.
“Nasal polyps can lead to loss of smell and often patients require surgery to remove the polyps,” Sally Seymour, MD, director, Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, said in the release.
“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 Seymour.
The efficacy and safety of dupilumab were demonstrated in two phase 3 studies with 724 patients, age 18 years and older, with chronic rhinosinusitis with nasal polyps who continued to have symptoms despite taking intranasal corticosteroids.
Treatment with dupilumab led to statistically significant reductions in nasal polyp size and nasal congestion compared with a placebo. Patients taking dupilumab also reported an increased ability to smell and required less nasal polyp surgery and oral steroids.
“Treatment with Dupixent also reduced the need for systemic steroids and surgery, and led to improvements in health-related quality of life. Importantly, these patients with co-morbid asthma now have a treatment that can help improve their breathing,” John Reed, MD, PhD, head of research and development at Sanofi, said in a joint news release from Sanofi and Regeneron Pharmaceuticals.
“This approval further reinforces that IL-4 and IL-13 are key drivers of type 2 inflammation, and we continue to study Dupixent in other type 2 inflammatory diseases, including eosinophilic esophagitis, and food and environmental allergies,” added George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron.
Dupilumab comes in a 300 mg prefilled syringe for patients with chronic rhinosinusitis with nasal polyps. It is given as a subcutaneous injection every other week at different injection sites.
The most common side effects with dupilumab in chronic rhinosinusitis trials were injection site reactions, conjunctivitis, arthralgia, and gastritis. Full prescribing information is available online.