Sanofi: approval of Dupixent for COPD in the EU
This approval is based on two pivotal Phase III studies showing that Dupixent significantly reduces disease exacerbations and improves lung function, as well as health-related quality of life.
With this decision by the European Medicines Agency, Dupixent is the first new medicine for the treatment of COPD in over a decade, and a new treatment option for around 220,000 adult patients in the EU.
This is the sixth indication approved for Dupixent in the EU, and the seventh worldwide. Other regulatory submissions are currently under review by various regulatory agencies, particularly in the US, Japan and China.
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