With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.
The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.
“I’ve never in my career had an approval this fast, which is amazing,” Patel told Endpoints News ahead of the announcement.
The label expansion comes as CEO Paul Hudson lays out some audacious goals for Dupixent, promising to make it one of the biggest drug franchises in biopharma history with an estimated $14.5 billion in peak sales.