In a late stage trial Dupixent, jointly developed with Regeneron (REGN.O), led to a 30% reduction in moderate or severe acute exacerbations of chronic obstructive pulmonary disease (COPD), a potentially deadly disease marked by progressive lung function decline.
Sanofi previously forecast Dupixent would generate up to 13 billion euros ($14.2 billion) in sales in its best year as it seeks to widen its use across several inflammatory conditions.
The anti-inflammatory drug accounted for 8.3 billion euros, or more than 19%, of the French group's overall sales of 43 billion euros last year.
Sanofi reports combined global Dupixent sales from its alliance with Regeneron.
Dupixent was also approved by the EC to treat eosinophilic esophagitis, a condition that damages the esophagus, in January.