The approval is based on efficacy and safety data of dupilumab from 2 clinical studies: the 24-week SINUS-24 and 52-week SINUS-52.
Officials with the FDA today approved dupilumab (Dupixent, Regeneron and Sanofi) for the treatment of inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults, according to a press release. Dupilumab is the first biologic medicine approved for this indication.
CRSwNP often occurs with severe asthma and requires systemic steroids or nasal surgery, the current standard of care. However, uncontrolled CRSwNP can lead to debilitating symptoms, including breathing difficulties, nasal congestion and discharge, reduced or loss sense of smell and taste, and facial pressure.
The approval is based on efficacy and safety data of dupilumab from 2 clinical studies: the 24-week SINUS-24 and 52-week SINUS-52. The trial program included 724 patients aged 18 years and older with CRSwNP who were symptomatic despite taking intranasal corticosteroids. For the studies, patients received dupilumab 300 mg every 2 weeks with standard-of-care mometasone furoate nasal spray (MFNS) compared with a placebo injection plus MFNS.
Overall, patients treated with dupilumab achieved statistically significant improvements in all primary and secondary endpoints at 24 weeks, including:
Additionally, a pre-specified pooled analysis of the 2 trials up to 52 weeks showed that dupilumab significantly reduced systemic corticosteroid use and the need for sino-nasal surgery compared with placebo. Overall, the proportion of patients who required systemic corticosteroids was reduced by 74% with dupilumab compared with placebo. The proportion of patients who required surgery was reduced by 83% with dupilumab compared with placebo, according to the study.
The most common adverse effects reported in the clinical trials were injection site reactions, conjunctivitis, arthralgia, and gastritis.
“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, current standards of care,” George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron, said in a statement. “Importantly, many patients with CRSwNP also suffer from asthma, and Dupixent was shown to improve lung function.”
Fifty-nine percent of patients demonstrated improvements in lung function that were similar to the patients in the dupilumab asthma program, according to the data.
“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,” Yancopoulos said.
Dupilumab is administered by subcutaneous injection with a 300 mg pre-filled syringe for patients with CRSwNP every other week at different injection sites. It is also approved for indications in moderate-to-severe asthma and moderate-to-severe atopic dermatitis.
FDA Approves Dupixent (dupilumab) for Chronic Rhinosinusitis with Nasal Polyposis [news release]. Regeneron. https://investor.regeneron.com/news-releases/news-release-details/fda-approves-dupixentr-dupilumab-chronic-rhinosinusitis-nasal. Accessed June 26, 2019.