Following the news that Sanofi and Regeneron announced that the Food and Drug Administration (FDA) accepted a Priority Review of the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) in patients ages 12 years and older with eosinophilic esophagitis (EoE), a chronic allergic inflammatory disease of the esophagus;

Mandana Emamzadeh, PhD, Healthcare Analyst at GlobalData, a leading data and analytics company, offers her view:

“If approved, Sanofi and Regeneron’s Dupixent will be the first medicine available in the US for EoE. Dupixent is of particular interest, as it is the only pipeline agent being studied in Phase III for a younger population (ages 1–11 years old). It is already used with asthma and eczema in children and a label expansion to young EoE patients is expected soon after reaching the adult and adolescent market.

“Dupixent offers promise to these patients, after Takeda exited the market in February 2022. Key opinion leaders (KOLs) interviewed by GlobalData had been hopeful that Eohilia would be first to market, but unfortunately its journey came to an end.

“However, Takeda’s exit opened the field for other manufacturers, including Sanofi and Regeneron; alongside Bristol Myers Squibb, with its cendakimab (RPC-4046), and AstraZeneca, with Fasenra (benralizumab).

“Although Dupixent will be a first-in-class drug for EoE, KOLs believed that it will likely be effective for a small patient population who are not responsive to off-label proton pump inhibitors and corticosteroids in the first and second lines of therapy, respectively. However, the launch of high-price Dupixent for adolescents and adults is expected to increase sales in this space significantly, representing the most impactful driver of growth for the EoE market.”