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Europe Approves Sanofi/Regeneron's Dupixent for 'Smoker's Lungs' A Month After US FDA Asks For Data

On Wednesday, the European Medicines Agency (EMA) approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. Specifically, the approval covers patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA) or on a combination of LABA and LAMA if ICS is not appropriate. Sanofi SA (NASDAQ:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) are jointly developing dupilumab under a global collaboration agreement. The EMA is the first regulatory authority in the world to approve Dupixent for COPD patients. Read Next: Regeneron’s Dupixent COPD Sales To Reach $20B By 2026, Analyst Sees Larger Addressable Market. Dupixent is the ...