FDA accepts sBLA for dupilumab to treat CRSwNP in patients aged 12 to 17 years

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The federal agency has accepted the sBLA for Priority Review designation, with a target action date of September 15, 2024.

FDA accepts sBLA for dupilumab to treat CRSwNP in patients aged 12 to 17 years | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.

FDA accepts sBLA for dupilumab to treat CRSwNP in patients aged 12 to 17 years | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.

According to an announcement from Regeneron Pharmaceuticals and Sanofi, the FDA has accepted, for Priority Review Designation, the supplemental Biologics License Application (sBLA) for dupilumab (Dupixent) as an add-on maintenance treatment for patients aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).1

With the sBLA accepted, the federal agency has provided the companies with a decision date of September 15, 2024.1

CRSwNP is a recurring disease of the upper airway, driven in part by type 2 inflammation that obstructs the sinuses and nasal passages. The disease can cause difficulty breathing, nasal congestion and discharge, reduced or loss of sense of smell and taste, facial pressure, sleep disturbance, and overall reduction in quality of life.1

Co-morbid diseases such as asthma, can lead to an increased risk of asthma attacks, high symptom burden, and a substantial adverse impact on health-related quality of life, stated Regeneron.1

Support for the accepted sBLA comes from an extrapolation of efficacy data from 2 positive trials in adults with CRSwNP (SINUS-24 and SINUS-52). The trails demonstrated that dupilumab "significantly improved nasal congestion/obstruction severity, nasal polyp size and sense of smell, while also reducing the need for systemic corticosteroids or surgery, at 24 weeks compared to placebo," stated Regeneron in the announcement press release. The trials met all their primary and secondary outcomes, respectively.1,2

Patients treated with dupilumab added to a standard-of-care corticosteroid nasal spray experienced a 51% and 57% improvement in their nasal congestion/obstruction severity, compared to a 15% and 19% improvement with placebo (-1.25 and -1.34 for Dupixent compared to -0.38 and -0.45 for placebo, on a 0-3 scale), according to data previously announced by Regeneron.2

In addition, dupilumab-treated patients had a 27% and 33% reduction in their nasal polyps score compared to a 4% and 7% increase for placebo (-1.71 and -1.89 for Dupixent compared to 0.10 and 0.17 for placebo, on a 0-8 scale that measures bilateral polyps size by endoscopy).2

The sBLA was also supported by dupilumab safety data in its currently approved indications for adolescents.1

In the United States, dupilumab is a prescription medication approved for the following pediatric indications1:

  • Adults and children aged 6 months and older with moderate-to-severe atopic dermatitis that is not well controlled with topical prescription therapies, or for those who cannot use topical therapies.
  • With other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in children aged 6 years and older, whose asthma is not controlled with current asthma medications.
  • To treat adults and children aged 1 year and older with eosinophilic esophagitis (EoE) who weigh at least 33 pounds. The indication was granted FDA approval on January 25th, 2024.

According to Regeneron, the most common side effects of dupilumab for eczema treatment include injection site reactions, eye and eyelid inflammation, dry eye, cold sores in mouth and on lips, and high count of a certain white blood cell (eosinophilia).1

For Asthma, the most common side effects are injection site reactions, high count of a certain white blood cell (eosinophilia), oropharyngeal pain, and parasitic (helminth) infections.1

The most common side effects for CRSwNP include injection site reactions, eye inflammation, high count of a certain white blood cell (eosinophilia), gastritis, joint pain, insomnia, and toothache.

Lastly, for EoE, the most common side effects include injection site reactions, upper respiratory tract infections, cold sores in mouth and on lips, and join pain.

References:

1. Dupixent (dupilumab) sBLA accepted for FDA Priority Review for treatment of adolescents with chronic rhinosinusitis with nasal polyposis (CRSwNP). Regeneron PHarmaceuticals. Press release. May 13, 2024. Accessed May 13, 2024. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-sbla-accepted-fda-priority-review-0

2. Dupixent (dupilumab) showed positive topline results in two phase 3 trials of patients with chronic rhinosinusitis with nasal polyps. on PHarmaceuticals. Press release. October 16, 2018. Accessed May 13, 2024. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-showed-positive-topline-results-two-phase-3

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