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FDA Decision on Dupilumab for COPD Pushed Back to September 2024


FDA has no concerns about the "approvability" of dupilumab for the new indication but needs additional time to review phase 3 data it requested early in May.

Regeneron announced today1 that the US Food and Drug Administration (FDA) has extended by 3 months the target action date of the priority review granted to the company and partner Sanofi’s supplemental biologics license application (sBLA) for dupilumab as add-on maintenance therapy in adults with uncontrolled chronic obstructive pulmonary disease (COPD) with type 2 inflammation.

The original date of June 27 has been pushed back to September 27, according to the Regeneron announcement.1

The agency did not raise concerns about the “approvability” of the biologic for the additional indication, Regeneron said. The FDA will use the 3-month period to review additional analyses it requested in early May from Sanofi and Regeneron of the 2 pivotal phase 3 clinical trials, BOREAS and NOTUS. The agency concluded that the supplemental data “constituted a major amendment to the sBLA,” and so “extended the target action date accordingly,” according to Regeneron.1

“Regeneron and Sanofi are confident that the additional analyses strongly support the approval of Dupixent in COPD with evidence of type 2 inflammation and are committed to working with the FDA to bring Dupixent to patients living with uncontrolled COPD as quickly as possible.”1

The fully human monoclonal antibody inhibits both interleukin 4 and 13 (IL-4, IL-13), a mechanism of action demonstrated across the dupilumab development program to decrease type 2 inflammation in patients with atopic or allergic diseases. Identifying the central role of IL-4 and IL 13 in the type 2 inflammatory cascade has led to pivotal clinical trials resulting in FDA approval of dupilumab as primary or add-on treatment for individuals with asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), and prurigo nodularis, according to the statement.1

Lead investigator for the BOREAS and NOTUS trials Surya Bhatt, MD, director of the University of Alabama at Birmingham Lung Imaging Lab, highlighted the significance of the former trial’s findings, confirmed by the latter, in an interview in May with Patient Care.2 Describing the impact of dupilumab on the studies’ primary endpoint, the annualized rate of disease exacerbations in high-risk patients with COPD and blood eosinophil counts of ≥300 cells per mL, Bhatt explained: “In BOREAS, there was a 30% reduction in the exacerbation frequency and in NOTUS the reduction was 34%. This was on top of triple therapy which was considered standard-of-care in the comparator arm. And, in contrast to several other biologic studies, in both BOREAS and NOTUS there was a significant improvement in lung function."2

Bhatt described the exacerbation reduction outcomes as “truly remarkable,” and explained that dupilumab “likely has a broader clinical effect on type 2 inflammation” compared with standard-of-care triple therapy that includes bronchodilators and inhaled corticosteroids. It is hypothesized that the biologic may have disease modifying properties, including “improving airway epithelial barrier dysfunction, improving airway remodeling, decreasing goblet cell hyperplasia, and thereby mucus production,” Bhatt said.2

Dupilumab is in a position to become the first biologic agent approved for treatment of moderate-to-severe COPD and would represent the first new approach to disease management in more than a decade. “I think approval of dupilumab will completely change the [treatment] landscape and also offer hope for other biologics entering the therapeutic area. Dupilumab targets and important patient population who have a significant unmet need,” said Bhatt.2

He alluded to ongoing research that is evaluating other “more upstream pathways” as targets for biologic therapies. “We may soon…have a range of biologics that we can pick and choose from so that we can offer personalized targeted therapies based on the inflammatory profile or the endotype” of individuals living with COPD.”2

In a separate press statement released at the same time, Regeneron and Sanofi announced that the application for dupilumab as an add-on COPD therapy received a positive opinion recommending approval from the European Medicines Agency’s Committee for Medicinal Products for Human Use.3


1. Update on FDA priority review of Dupixent (dupilumab) for the treatment of COPD patients with type 2 inflammation. News release. Regeneron. May 31, 2024. Accessed May 31, 2024. https://investor.regeneron.com/news-releases/news-release-details/update-fda-priority-review-dupixentr-dupilumab-treatment-copd

2. Halsey G. Surya Bhatt, MD: Findings on Dupilumab for Patients with COPD, Type 2 Inflammation. Patient Care Online. Published February 27, 2024. https://www.hcplive.com/view/surya-bhatt-findings-on-dupilumab-for-patients-with-copd-type-2-inflammation

3. Dupixent (Dupilumab) recommended for EU approval by the CHMP to treat patients with COPD. News release. Regeneron. May 31, 2024. Accessed May 31, 2024. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-recommended-eu-approval-chmp-treat-patients 

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