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# FDA Extends Review of Dupixent in COPD
- URL: https://www.fdaweb.com/fda-extends-review-of-dupixent-in-copd/
- Published: 2024-05-31T12:00:00.000Z
- Updated: 2026-09-14T14:32:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157091

FDA has extended by three months its review of a Regeneron supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The company said earlier this month that the agency recently requested sub-population breakdowns from the Phase 3 BOREAS and NOTUS trials, which may require a review extension. “Our analyses across these requested patient subgroups indicate a consistent and clinically meaningful reduction in COPD exacerbations,” the company said at the time. The revised user fee review action target date is 9/27.

In February, FDA accepted the submission for priority review and set a 6/27 user fee review action target date. Regeneron says the submission is based on data from the Phase 3 COPD clinical research program evaluating the efficacy and safety of Dupixent in adults who were current or former smokers with uncontrolled COPD with evidence of Type 2 inflammation. “The primary endpoint was met in both trials ([BOREAS](https://www.sanofi.com/en/media-room/press-releases/2023/2023-05-21-18-17-12-2672904?ref=fdaweb.com), [NOTUS](https://www.sanofi.com/en/media-room/press-releases/2023/2023-11-27-06-30-00-2785836?ref=fdaweb.com)), showing Dupixent significantly reduced moderate or severe acute COPD exacerbations by 30% and 34% respectively, compared to placebo,” it says. In both trials, Dupixent reportedly improved lung function compared to placebo, with improvements sustained at 52 weeks.

Safety-related results in both trials were generally consistent with the known safety profile of Dupixent in its approved indications, the company says. “Adverse events more commonly observed with Dupixent compared to placebo in either trial were back pain, Covid-19, diarrhea, headache and nasopharyngitis,” it adds.

Monoclonal antibody Dupixent works by inhibiting the signaling of the IL-4 and IL-13 pathways, according to the company. It’s currently approved for treating atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and prurigo nodularis.