Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNY) Friday said the National Medical Products Administration (NMPA) in China has approved Dupixent as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils.
The approval is based on results from the BOREAS and NOTUS Phase 3 studies, in which Dupixent significantly reduced exacerbations and improved lung function, compared to placebo. Improvements in health-related quality of life were also observed.
COPD is the most prevalent chronic respiratory disease in China, and is a priority within the government's Healthy China 2030 public health plan, the company said in a statement.
Dupixent for the treatment of COPD has been approved in more than 30 countries across the world, including the 27 countries in the European Union.
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