Sanofi, Regeneron's Dupixent gets FDA priority review for eosinophilic esophagitis
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Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NASDAQ:SNY) said the U.S. Food and Drug Administration (FDA) granted priority review to Dupixent to treat patients aged 12 years and older with eosinophilic esophagitis (EoE).
The companies said that if approved, Dupixent (dupilumab) would be the first medicine available in the U.S. indicated to treat EoE, a chronic and progressive type 2 inflammatory disease that damages the esophagus and impairs the ability to swallow.

The FDA is expected to make a decision on the biologics license application (sBLA) by Aug. 3.
The sBLA is backed by data from two phase 3 trials and an active long-term extension trial of Dupixent 300 mg.
The companies noted that the drug improved the symptoms of EoE at 24 weeks compared to placebo, including the ability to swallow and reduction in eosinophil count in the esophagus.
Dupixent has already received the FDA's breakthrough therapy and orphan drug designations for EoE.
Dupixent is approved to treat patients with certain types of atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis.
In March, Sanofi raised the peak sales expectations of Dupixent to more than â¬13B.