Dupilumab sBLA Accepted for Severe Chronic Rhinosinusitis with Nasal Polyps Indication

Jennifer Barrett, Associate Editor
Published Online: Friday, March 8th, 2019
Officials with the FDA have granted Priority Review status to the supplemental Biologics License Application (sBLA) for dupilumab (Dupixent) as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP), according to a press release.1 
If approved, dupilumab would be the first FDA-approved biologic for the treatment of CRSwNP. CRSwNP is a chronic disease, in which individuals with severe disease typically experience recurrent inflammation of the upper airway despite previous surgery and/or systemic corticosteroids.1
The sBLA submission is based on data from 2 phase 3 trials, SINUS-24 and SINUS-52, evaluating the efficacy and safety of 300 mg dupilumab every 2 weeks with standard-of-care mometasone furoate nasal spray (MFNS) compared with a placebo injection plus MFNS. Study participants had recurring severe CRSwNP and had been previously treated with surgery and/or systemic corticosteroids. In addition, SINUS-52 included a third patient group who switched from dupilumab every 2 weeks to dupilumab every 4 weeks after week 24. In the trials, approximately 60% of patients had comorbid asthma, with most of them receiving asthma controller medications.1
Data from these trials were presented at the Annual Meeting of the American Academy of Allergy, Asthma, and Immunology in February 2019.
According to Regeneron, key data from the trial showed:2
  • 42% and 27% improvement in sinus opacification versus 4% and 0% with a placebo at 24 weeks in SINUS-24 and SINUS-52, respectively.
  • 146% and 108% improvement in ability to identify different smells versus 19% and 7% with placebo at 24 weeks in SINUS-24 and SINUS-52, respectively.
  • 60% and 51% improvement in health-related quality of life versus 18% and 18% with placebo at 24 weeks, respectively.
  • 0.21L improvement in lung function versus placebo at 24 weeks in SINUS-24 in the subset of patients with asthma at baseline and 0.21L improvement in lung function versus placebo in SINUS-52.
  • 73% reduction in rescue treatment with systemic corticosteroids or nasal polyp surgery compared with placebo at 24 weeks SINUS-24 and 76% reduction at 52 weeks in SINUS-52.
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