FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Drugmakers Push Back Against Exclusion Criteria for Rare Disease Trial

April 16, 2019
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Two drug companies are pushing back against proposed FDA guidance that would require drug sponsors to hold pre-trials to determine whether patients with a nasty form of esophageal swelling could benefit from an alternate therapy.

Eosinophilic esophagitis is a rare disease of the immune system that can cause vomiting, difficulty swallowing, persistent heartburn and food getting struck in a patient’s esophagus. In February, the FDA published draft guidance that, among other things, would require drugmakers to screen out patients who would respond to proton pump inhibitor (PPI) therapy by holding a two-month trial of an “adequate dose” of PPI.

In public comments, both AstraZeneca and Adare Pharmaceuticals asked the agency to reconsider that recommendation.

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