07:38 AM EDT, 09/27/2024 (MT Newswires) -- Sanofi ( SNY ) and Regeneron Pharmaceuticals ( REGN ) said Friday that China's National Medical Products Administration has approved Dupixent as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease, or COPD, characterized by raised blood eosinophils.
The companies said the approval particularly covers patients who are under treatment using a combination of an inhaled corticosteroid or ICS, a long-acting beta2-agonist or LABA, and a long-acting muscarinic antagonist or LAMA, or a combination of a LABA and a LAMA.
The approval was based on the results of two phase 3 studies, where Dupixent "significantly reduced" COPD exacerbations in all enrolled patients and "significantly improved" lung function compared with placebo, according to the statement.
Sanofi ( SNY ) and Regeneron Pharmaceuticals ( REGN ) said Dupixent has been approved as a treatment for COPD in over 30 countries and additional submissions are under review, including in Japan and the US.
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