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The approval was based on efficacy and safety data from a phase 3 trial, which included two 24-week treatment periods in patients 12 years of age and older with EoE.
Dupilumab is an interleukin-4 receptor alpha antagonist.
The FDA stated that the application could not be approved in its present form and recommended an additional clinical study.
Tezepelumab is a first-in-class human monoclonal antibody that works by blocking thymic stromal lymphopoietin.
Etrasimod is an investigational, next generation, once-daily, oral, highly selective sphingosine 1-phosphate receptor modulator.