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New Indication Alert: Dupixent (Dupilumab) Approved for COPD in EU

Jul 3, 2024

On 3 July 2024, Sanofi and Regeneron announced that the European Medicines Agency (EMA) approved their Dupixent® (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils.  This is the first approval of Dupixent for COPD anywhere in the world, and the sixth approved indication for the drug in the EU.   

Dupixent was recommended by the CHMP for COPD on 31 May 2024.  In February 2024, the FDA accepted Dupixent® for priority review for the same indication.  The target action date for the FDA decision was 27 June 2024 but, on 31 May 2024, was revised to 27 September 2024.