Europe Approves Regeneron-Sanofi's Dupixent For Expanded Use In Eosinophilic Esophagitis

The European Commission approved Regeneron Pharmaceuticals Inc REGN and Sanofi SA's SNY Dupixent (dupilumab) for expanded use in eosinophilic esophagitis (EoE) in adults and adolescents 12 years and older.
The approval covers patients inadequately controlled by, intolerant to, or not candidates for conventional medicinal therapy.
EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly.
"This latest approval establishes Dupixent as the only targeted medicine specifically indicated for eosinophilic esophagitis in the European Union," said George D. Yancopoulos, President and Chief Scientific Officer at Regeneron.
The decision is supported by 52-week data from a Phase 3 trial consisting of three parts (Part A, B, and C).
Part A and Part B investigated Dupixent 300 mg weekly (Part A n=42; Part B n=80) compared to placebo (Part A n=39; Part B n=79) for 24 weeks.
Part C (n=188) observed patients who had continued or switched to Dupixent from Parts A and B for an additional 28 weeks.
Dupixent patients in Parts A and B, respectively, experienced:
An approximately ten times higher rate of histological disease remission (60% and 59%), a co-primary endpoint, compared to placebo (5% and 6%).
A 69% and 64% reduction in disease symptoms compared to 32% and 41% with placebo. On disease symptoms, Dupixent patients experienced a 21.9- and 23.8-point clinically meaningful improvement compared to a 9.6- and 13.9-point improvement for placebo, a co-primary endpoint.
Swallowing improvement was observed as early as four weeks.
Price Action: REGN shares closed at $742.83 on Friday. SNY shares are up 0.95% at $48.95 during the premarket session on the last check Monday.

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