REGENERON PHARMACEUTICALS — Dupixent FDA Review (NDA/BLA 761055, 2026)
Regeneron Pharmaceuticals, Inc. · 2026 · FDA Review (Drugs@FDA) · company profile →
Report summary
This report summarizes the FDA review of Regeneron's Dupixent (dupilumab), detailing its approval for multiple indications including moderate-to-severe atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis. It covers clinical pharmacology, pharmacokinetics, and efficacy from studies demonstrating improvements in FEV1, exacerbation rates, and nasal polyp scores. The report also addresses regulatory updates, specifically the approval and review of new 300 mg pre-filled pen and autoinjector presentations. Comparative studies confirmed comparable bioavailability and efficacy between autoinjector and prefilled syringe devices, with human factors validation ensuring user safety and proper dosing. Safety information, including adverse reactions and warnings, is also included.
Key findings — cited to the page
| Number of subjects enrolled in AS Trials 1, 2, and 3 | 2888 | · p.32 |
| Number of subjects in AS Trial 1 | 776 | AS Trial 1 · p.32 |
| Withdrawal due to adverse event (Combined) | 3.3 % | · p.84 |
| Approval Date | June 18, 2020 | DUPIXENT · p.1 |
| Indication | As an 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 · p.1 |
| Patients withdrawn from treatment (Combined) | 7.8 % | · p.84 |
| Number of major protocol deviations (PFS) | 11 | · p.85 |
| Number of major protocol deviations (Combined) | 17 | · p.85 |
| Withdrawal of consent by subject (PFS) | 4.5 % | · p.84 |
| Indication | For the treatment of patients aged 6 years and older with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. | DUPIXENT · p.1 |
| Patients withdrawn from treatment (PFS) | 9.1 % | · p.84 |
| Number of subjects in AS Trial 1 (DUPIXENT 200 mg Q2W arm) | 150 | AS Trial 1 · p.32 |
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 →