Boehringer Ingelheim International GmbH will likely need to conduct another trial for empagliflozin after the US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee voted 14-2 that the benefits do not outweigh the risks as an adjunct to insulin to improve glycemic control in adults with type 1 diabetes mellitus.
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.
