Sanofi (NASDAQ: SNY), a French multinational pharmaceutical company, announced last week that the US Food and Drug Administration (FDA) has accepted for priority review an indication extension filing for its interleukin blocker Dupixent (dupilumab). The drug is proposed as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD), with the regulatory process expected to conclude by June 27, 2024. The submission is supported by data from two Phase III studies that demonstrated the drug’s efficacy in significantly reducing moderate or severe acute COPD exacerbations, with decreases of 30% and 34% compared to placebo.
These data are concurrently under review in China and the European Union, potentially positioning Dupixent to become the only biologic therapy approved for COPD. Currently, Dupixent is authorized for the treatment of a range of conditions including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis, and chronic spontaneous urticaria (CSU).- Flcube.com
