Sanofi wins FDA label expansion for Dupixent for new inflammatory condition
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Sanofi (NASDAQ:SNY) (OTCPK:SNYNF) received U.S. regulatory approval for its Dupixent injection as a treatment for eosinophilic esophagitis, a condition of allergic inflammation of the esophagus, the U.S. Food and Drug Administration (FDA) announced on Friday.
According to Sanofi (SNY), more than 160,000 Americans suffer from eosinophilic esophagitis, taking medications that are not specifically authorized for the disease. The approval allows the use of Dupixent for the indication in patients aged 12 year and older.
The best-selling treatment jointly developed by the French drugmaker with its U.S. partner Regeneron (REGN) is already approved for conditions such as atopic dermatitis in the U.S.
Dupixent generated â¬5.25 billion in sales for Sanofi (SNY) in 2021, accounting for about 14% of the company's topline.
In March, Sanofi (SNY) projected Dupixent to generate peak annual sales of over â¬13 billion ($13.77 billion), excluding its potential use in chronic obstructive pulmonary disease (COPD) for which trial results are expected next year.