Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the U.S. Food and Drug Administration has approved Dupixent as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease, or COPD, and an eosinophilic phenotype. “Dupixent is the first biologic medicine approved in the U.S. to treat these patients,” the companies stated. “This latest FDA approval for Dupixent represents new hope for the hundreds of thousands of COPD patients in the U.S. who can sometimes struggle just to breathe during their everyday lives. Dupixent has a proven track record as a first-in-class medicine, providing benefit to the many patients suffering from type 2 inflammatory related diseases such as asthma and atopic dermatitis. This latest approval represents an important next chapter for Dupixent, giving those with COPD a novel option that has demonstrated the unprecedented ability to help patients experience fewer exacerbations, while also helping them breathe better and improve quality of life in Phase 3 trials,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent.
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