REGENERON PHARMACEUTICALS — Dupixent FDA Review (NDA/BLA 761055, 2022)
Regeneron Pharmaceuticals, Inc. · 2022 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Regeneron's Dupixent (dupilumab) on May 20, 2022, for eosinophilic esophagitis (EoE) in patients aged 12 and older. This approval, following Breakthrough Therapy Designation, was based on efficacy demonstrated in Study 1774 (Parts A and B), showing significant improvements in histologic response and dysphagia symptoms with the 300 mg weekly dosage. While the safety profile was generally consistent with other indications, upper respiratory tract infections were noted in EoE patients. The report details the regulatory process, clinical trial designs (including for asthma and CRSwNP), safety data (hypersensitivity, eosinophilia, immunogenicity), pharmacokinetic data, and post-marketing requirements to assess long-term safety and address concerns like arthralgia. Instructions for use and patient labeling were also reviewed.
Key findings — cited to the page
| Trial Completion Date (4276-2) | 04/2023 | Dupixent · p.7 |
| Approval Date | May 20, 2022 | Dupixent · p.1 |
| Postmarketing Commitment (4276-2) | A one-year, randomized, double-blind trial to evaluate the safety, efficacy, and pharmacokinetics of Dupixent (dupilumab) in pediatric patients 1 to less than 12 years of age with active eosinophilic esophagitis. | Dupixent · p.7 |
| Final Report Submission Date (4276-1) | 03/2023 | R668-EE-1774 · p.6 |
| Conjunctivitis frequency (EoE, placebo) | 2 % | · p.23 |
| sBLA submission date | February 3, 2022 | Dupixent · p.4 |
| PDUFA Goal Date | August 3, 2022 | · p.82 |
| Indication | For the treatment of adult and pediatric patients ages 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis. | Dupixent · p.1 |
| Review Completion Date | May 20, 2022 | · p.82 |
| Required Postmarketing Study (4276-1) | Complete Part C of the ongoing clinical trial, R668-EE-1774, “A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis,” to evaluate the safety of long-term use of Dupixent (dupilumab) in adult and pediatric patients ages 12 years and older with eosinophilic esophagitis over 52 weeks of therapy. | R668-EE-1774 · p.6 |
| Trial Completion Date (4276-1) | 09/2022 | R668-EE-1774 · p.6 |
| Final Report Submission Date (4276-2) | 10/2023 | Dupixent · p.7 |
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 →