Regeneron Pharmaceuticals, Inc. — Dupixent FDA Review (BLA761055, SUPPL 14, 2019)
Regeneron Pharmaceuticals, Inc. · 2019 · FDA Review (openFDA) · company profile →
Report summary
The FDA approved Dupixent (dupilumab) for chronic rhinosinusitis with nasal polyposis (CRSwNP) based on a favorable benefit-risk assessment. This supplemental Biologics License Application (sBLA) review details Dupixent's mechanism of action, existing approvals for atopic dermatitis and asthma, and comprehensive efficacy and safety data from two pivotal Phase 3 trials (EFC14146 and EFC14280) in CRSwNP. These trials demonstrated significant improvements in nasal polyp score, nasal congestion, loss of smell, and reduced need for systemic corticosteroids/surgery. Safety findings were consistent with previous indications, with common adverse reactions including injection site reactions and conjunctivitis. The recommended dosing regimen is 300 mg every two weeks. Clinical inspections confirmed Good Clinical Practices, and the label review found no medication error vulnerabilities. The report also includes detailed instructions for Dupixent's use and storage.
Key findings — cited to the page
| Recommendation on regulatory action | Approval | · p.66 |
| Dupilumab approval for atopic dermatitis | March 2017 | Global · p.80 |
| Dosage form | Subcutaneous solution for injection | · p.66 |
| Applicant-proposed indication/population | Add-on maintenance in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis | · p.66 |
| Indication | add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP) | Dupixent · U.S. · p.9 |
| Discontinuation due to adverse events in placebo group (asthma) | 4% % | Dupixent · p.17 |
| Dry eye incidence in placebo monotherapy (atopic dermatitis) | 0 | Dupixent · p.16 |
| Indication | add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma | Dupixent · U.S. · p.9 |
| Dry eye incidence in DUPIXENT 300 mg Q2W + TCS (atopic dermatitis) | 2% % | Dupixent · p.16 |
| Applicant-proposed dosing regimen | 300 mg subcutaneous injection every other week | · p.66 |
| Dry eye incidence in placebo + TCS (atopic dermatitis) | <1% % | Dupixent · p.16 |
| Dupilumab approval for atopic dermatitis (pediatric expansion) | March 2019 | Global · p.80 |
Source: Regeneron Pharmaceuticals, Inc. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →