▎WuXiEdited by Kant Content Team

Regeneron Pharmaceuticals and Sanofi presented the latest data from the Phase 3 clinical trial NOTUS at the 2024 American Thoracic Society (ATS) International Conference. The trial evaluated the efficacy of Dupixent (dupilumab) as an add-on therapy for adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The data showed,In patients whose symptoms remain uncontrolled after receiving standard treatment and who have signs of type 2 inflammation (blood eosinophils ≥300 cells/μL), Dupixent reduced disease exacerbations by 34%.The press release noted that these data support Dupixent in becomingThe first new therapy for COPD in over a decade, and the first targeted therapy for COPD.The trial data were simultaneously published in The New England Journal of Medicine (NEJM）。

• InA 34% reduction in moderate or severe COPD exacerbations over 52 weeks (p<0.001)。

• The improvement in lung function from baseline to week 12 was more than double, the improvement in forced expiratory volume (FEV) before the use of bronchodilators in the Dupixent group was 139 mL, compared to 57 mL in the control group (p<0.001), and the improvement in lung function was maintained at week 52.

• At 52 weeks, health-related quality of life improved from baseline, and the severity of respiratory symptoms decreased.

Safety Results Generally Consistent with Dupixent’s Safety Profile in Approved Indications. The overall incidence of adverse events (AEs) was 67% in the Dupixent group and 66% in the placebo group. Adverse events more common in the Dupixent group than the placebo group included COVID-19 (Dupixent 9.4%, placebo 8.2%), nasopharyngitis (Dupixent 6.2%, placebo 5.2%), and headache (Dupixent 7.5%, placebo 6.5%). Adverse events more common in the placebo group than the Dupixent group included COPD (placebo 7.8%, Dupixent 4.9%). Fatal adverse events occurred in 2.6% of the Dupixent group and 1.5% of the placebo group.

Dupixent is currently under review by the U.S. FDA, and the supplemental Biologics License Application for the treatment of COPD has been granted.Priority Review StatusThe FDA is expected to complete the review by June 27, 2024.

Dupixent is a fully humanized monoclonal antibody that inhibits signaling in the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways.Previously, it had been approved by the FDA for the treatment of diseases including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), prurigo nodularis, and eosinophilic esophagitis (EoE).

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