04:15 AM EDT, 07/03/2024 (MT Newswires) -- Regeneron Pharmaceuticals ( REGN ) and Sanofi ( SNY ) said Wednesday the European Commission has approved Dupixent as an additional maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease, or COPD, a respiratory disease that damages the lungs.

The decision marks the first Dupixent approval worldwide for COPD patients, the companies said. Other applications are under review in the US, China and Japan.

The approved indication covers patients already being treated with various combinations of an inhaled corticosteroid, a long-acting beta2-agonist, and a long-acting muscarinic antagonist.

The European approval is based on results from two phase 3 trials in which patients given the drug showed reductions of 30% to 34% in "the annualized rate of moderate or severe COPD exacerbations over 52 weeks," the companies said.

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