Regeneron (REGN), SNY Win EC Approval for Dupixent for COPD [Yahoo! Finance]
Sanofi - American Depositary Shares (SNY)
US:NYSE Investor Relations:
sanofi.com/en/investors
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Source: Yahoo! Finance
The drug is now approved in the European Union (EU) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD), characterized by raised blood eosinophils. The approval of the COPD indication represents the sixth approved indication for Dupixent in the EU. The approval was mostly expected as the European Medicines Agency's Committee for Medicinal Products for Human Use gave a positive opinion recommending the approval of Dupixent for COPD in May 2024. This latest EC approval is based on positive results from two late-stage studies, BOREAS and NOTUS, which evaluated the efficacy and safety of Dupixent in adults who were current or former smokers with moderate-to-severe COPD with evidence of type 2 inflammation. Results showed that Dupixent significantly reduced exacerbations and improved lung function and health-related quality of life. COPD is a respiratory disease that damages the lungs and causes progressive lung function decli
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Sec Filings
- 7/2/24 - Form 6-K
- 6/28/24 - Form 11-K
- 6/28/24 - Form 11-K
- SNY's page on the SEC website