Sanofi, Regeneron chase 4th Dupixent approval with rare esophageal disease data

Sanofi and Regeneron’s immunology superstar Dupixent is well on its way to world domination with a flood of new indications in the pipeline. To support one of those, a rare esophageal disease, the partners released new data backing up Dupixent’s case for a fourth FDA approval. 

Dupixent improved patients’ ability to swallow and cut levels of targeted white blood cells over placebo in patients with eosinophilic esophagitis, a rare disease characterized by inflammation in the esophagus, according to late-breaking science presented this weekend at two gastroenterology virtual meetings. 

In Part A of a planned three-part clinical program, Dupixent improved patients’ ability to swallow after four weeks of treatment and maintained that benefit through six months, the drugmakers said. The drug also pared back eosinophil levels, reduced disease symptoms and changed patients’ gene expression for the disease at the 24-week mark. 

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The newest data followed up on top-line data released in May showing Dupixent reduced disease symptoms over placebo after 24 weeks of therapy. Dupixent received the FDA’s orphan drug designation in the disease back in 2017.

Dupixent, a blockbuster seller with three approvals under its belt, would become the first approved therapy for eosinophilic esophagitis. Sanofi and Regeneron are currently enrolling a Part B study in the disease, with a 28-week follow-up study planned. 

RELATED: How to get to $11B? For Sanofi and Regeneron’s Dupixent, 5 new approvals would help

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