China NMPA approves Sanofi & Regeneron’s Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD
The National Medical Products Administration (NMPA) in China has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. Specifically, the approval covers patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate. Dupixent for the treatment of COPD has been approved in more than 30 countries worldwide, including the 27 countries in the EU.
Under review submission: - Additional submissions for Dupixent in COPD are under review with regulatory authorities around the world, including in the US and Japan.
Sanofi and Regeneron are motivated to transform the treatment paradigm of COPD by examining the role different types of inflammation play in the disease progression through the investigation of two potentially first-in-class biologics, Dupixent and itepekimab.