In the middle of December, Sanofi 's (NASDAQ: SNY) and Regeneron Pharmaceuticals ' (NASDAQ: REGN) immunology drug Dupixent received more positive regulatory news. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended the drug's approval to treat eosinophilic esophagitis (EoE) patients who are 12 years old and up.
Dupixent is considered a mega-blockbuster drug (i.e., $5 billion-plus in annual sales). With approval of the indication likely just months away, the following two questions come to mind: What are the clinical trial results behind the CHMP's recommendation of Dupixent? And how much of an impact would approval have on Sanofi's sales?
To answer these questions, let's look at the results of Dupixent's phase 3 clinical trial and the EoE market in the European Union.
For further details see:
What This Drug News Could Mean for Sanofi Shareholders