Empagliflozin Likely Needs Another Trial After Rebuke By US FDA Panel

Expanded indication for type 1 diabetes seems out of reach for the moment, but if Boehringer conducts a larger and lengthier trial, it could eventually persuade members of the Endocrinologic and Metabolic Drugs Advisory Committee who voted 14-2 against supplemental approval of empagliflozin for the proposed 2.5mg dose.

FDA Advisory Committee Feature image

More from US FDA Performance Tracker

More from Regulatory Trackers