Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNY) have announced the U.S. Food and Drug Administration's approval of Dupixent as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Sanofi highlighted that Dupixent marks the nation's foremost biologic medicine approved for these conditions.
COPD is characterized as a respiratory disease that causes damage to the lungs and leads to a progressive decline in lung function. Symptoms include persistent cough, excessive mucus production, and shortness of breath.
This approval is supported by phase 3 studies, which demonstrated a reduction in exacerbations and improvements in lung function and health-related quality of life for patients treated with Dupixent compared to those given a placebo.
In July, the European Medicines Agency also approved Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD characterized by elevated blood eosinophils.
Sanofi noted that Dupixent is currently awaiting regulatory approvals in several countries worldwide, including Japan.
At present, Regeneron's stock is trading at $1,063.05, up 2.22 percent, while Sanofi's stock is trading at $57.90, up 1.60 percent on Nasdaq.
