Sanofi (NASDAQ:SNY) has received regulatory approvals for its drug Dupixent (dupilumab) in both China and the US for the treatment of adults with chronic obstructive pulmonary disease (COPD).
The National Medical Products Administration in China approved Dupixent for patients with raised blood eosinophils already on a specific combination of medications.
“The approval of Dupixent for COPD in China is critical, as it fills a gap in targeted therapy for the disease,” said Professor Kang Jian, Chair of the Chinese Association of Chest Physicians.
The US Food and Drug Administration has also approved Dupixent as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype.
The approvals were based on notable phase 3 studies that showed significant reductions in exacerbations and improvements in lung function and quality of life.
Following the announcement, Sanofi's share price held steady at $56.21.