FDA Approves Dupixent for Chronic Obstructive Pulmonary Disease
- By BSTQ Staff
The U.S. Food and Drug Administration (FDA) has expanded its approval of Dupixent to chronic obstructive pulmonary disease (COPD). This permits Dupixent’s use as an add-on maintenance treatment of adults whose COPD is inadequately controlled by available therapies. The every-other-week injectable drug is now the first biologic therapy approved by the FDA for treating COPD, and is the sixth FDA-approved indication for the drug.
Dupixent is an antibody designed to block IL-13 and IL-4, two signaling pathways that drive inflammation. In COPD, the drug is intended to specifically address type 2 inflammation, an excessive immune response characterized by accumulation of certain immune cells in tissue. Dupixent’s FDA approval in COPD covers the drug’s use to treat patients whose disease is driven by immune cells called eosinophils.
Approval is based on results from two Phase III studies that compared the drug to a placebo in adults who were currently receiving standard-of-care inhaled therapy. Results for both studies showed statistically significant reductions in the annualized rate of moderate or severe COPD exacerbations measured over one year.
References
Vinluan, F. Sanofi and Regeneron Biologic Drug Dupixent Notches a New FDA Approval in COPD. MedCityNews, Sept. 29, 2024. Accessed at medcitynews.com/2024/09/sanofi-regeneron-copd-dupixent-fda-approval-biologic-drug.
