Regeneron (REGN) and Sanofi (SNY) announced that the European Commission, or EC, has approved Dupixent as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease, or COPD, characterized by raised blood eosinophils. Specifically, the approval covers patients already on a combination of an inhaled corticosteroid, or ICS, a long-acting beta2-agonist, or LABA, and a long-acting muscarinic antagonist, or LAMA, or on a combination of a LABA and a LAMA if ICS is not appropriate. The EC is the first regulatory authority in the world to approve Dupixent for COPD patients. Additional submissions are under review with other regulatory authorities around the world, including in the U.S., China and Japan.
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