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Sanofi's Dupixent Gains EMA Approval for COPD, 'Smoker's Lung'; FDA Review Extended to September 27

May 31, 2024, 06:14 AM

Sanofi's drug Dupixent has received backing from the European Medicines Agency (EMA) for use in treating chronic obstructive pulmonary disease (COPD), a chronic lung disorder often referred to as 'smoker's lung'. This approval opens a new growth avenue for the blockbuster drug. However, the U.S. Food and Drug Administration (FDA) has extended its review deadline for Dupixent, requesting more data on its efficacy for treating COPD in patients with Type 2 inflammation. The FDA's revised Prescription Drug User Fee Act (PDUFA) action date is now set for September 27, 2024. Sanofi has partnered with Regeneron Pharmaceuticals in the development and marketing of Dupixent. The Committee for Medicinal Products for Human Use (CHMP) has also backed the drug.