BRIEF—Breakthrough Therapy designation for Dupixent

The US regulator has granted Breakthrough Therapy designation to Sanofi’s Dupixent (dupilumab) in eosinophilic esophagitis (EoE), based on positive results from Part A of a Phase III trial.

There are currently no FDA-approved medicines for EoE, a chronic and progressive inflammatory disease that damages the throat.

Sanofi has been developing the option together with US biotech Regeneron. Breakthrough Therapy designation, which enables expedited regulatory review, follows the award of Orphan Drug designation in this indication in 2017.