FDA Extends Dupilumab COPD Decision to September 2024

The US Food and Drug Administration (FDA) has extended the target action date of the priority review designated for Regeneron Pharmaceutical and Sanofi’s application to indicate dupilumab (Dupixent) as an add-on treatment of clinically relevant adult patients with uncontrolled chronic obstructive pulmonary disease (COPD).¹

The PDUFA date for the company’s supplemental Biologic License Application (sBLA) has therefore moved from June 27 to September 27 this year.

According to a press release from Regeneron, the FDA did not raise any concerns regarding the validity of dupilumab to treat the proposed indication in this delay. Rather, the agency is requesting additional efficacy analyses from the pivotal BOREAS and NOTUS trials.

“Based on the submission of these analyses earlier in May, the agency has now determined that this additional information constituted a major amendment to the sBLA and extended the target action date accordingly,” the companies’ statement read. “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.”

Regeneron and Sanofi additionally announced on Friday morning their application for dupilumab as an add-on COPD therapy received a positive opinion of recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for a similar application through EMA.²

A dual interleukin 4 and 13 (IL-4; IL-13) inhibitor, dupilumab is among the preeminent biologic therapies for the management of type 2 inflammation in patients with atopic or allergic diseases. It has previously been approved by the FDA as an add-on or primary treatment for patients with asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), and prurigo nodularis.

In an interview with HCPLive earlier this year, Surya Bhatt, MD, BOREAS and NOTUS investigator and director of the University of Alabama at Birmingham (UAB) Lung Imaging Lab, discussed the significance of the trial’s findings that which showed a 34% reduction COPD exacerbations in high-risk patients with blood eosinophil counters ≥300 cells per mL versus triple inhaler therapy.³

Bhatt described the exacerbation reduction outcomes as “truly remarkable,” noting that dupilumab was on track to become the first biologic indicated to treat patients with COPD.

“I think we will see a large shift in the treatment landscape,” Bhatt explained. “The effect of exacerbations is not just on short term morbidity, in terms of how the patient feels, but also has long term effects in terms of disease progression. There are significant data to suggest that exacerbations result in more lung function decline, and also in progression of emphysema.”

Bhatt additionally highlighted the broad clinical benefit of dupilumab on type 2 inflammation relative to standard care bronchodilators and inhaled corticosteroids for patients with COPD.

“So, in that sense, I think it is potentially a disease modifier,” Bhatt said. ”There are several speculated mechanisms of action, including reduction of mucus production, decreasing the contractility of airway smooth muscles thereby enhancing bronchodilation.”

References

1. ^{Regeneron. UPDATE ON FDA PRIORITY REVIEW OF DUPIXENT® (DUPILUMAB) FOR THE TREATMENT OF COPD PATIENTS WITH TYPE 2 INFLAMMATION. Press release. Published May 31, 2024. https://investor.regeneron.com/news-releases/news-release-details/update-fda-priority-review-dupixentr-dupilumab-treatment-copd}
2. ^{Regeneron. DUPIXENT® (DUPILUMAB) RECOMMENDED FOR EU APPROVAL BY THE CHMP TO TREAT PATIENTS WITH COPD. Press release. Published May 31, 2024. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-recommended-eu-approval-chmp-treat-patients}
3. ^{Smith T. Surya Bhatt, MD: Findings on Dupilumab for Patients with COPD, Type 2 Inflammation. HCPLive. Published February 27, 2024. https://www.hcplive.com/view/surya-bhatt-findings-on-dupilumab-for-patients-with-copd-type-2-inflammation}