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Empagliflozin Likely Needs Another Trial After Rebuke By US FDA Panel

Executive Summary

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.

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