FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Issues Recommendations for Esophagitis Drug Trials

Feb. 13, 2019
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The FDA released draft guidance on clinical trial designs for treatments of eosinophilic esophagitis (EoE), a chronic inflammatory disease, including recommendations for selecting trial participants.

The randomized, double-blind, placebo-controlled trials should include a prespecified screening period before patients are randomized to confirm their eligibility, the agency said.

Trials conducted to support a drug’s marketing approval should evaluate the drug’s effect on both symptoms and the underlying inflammation of the disease by assessing the coprimary endpoints in Phase 3 trials.

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