Boehringer's Empagliflozin Heads To Advisory Cmte. With Questions On Treatment Effect
Boehringer wants supplemental empagliflozin claim as insulin adjunct to improve glycemic control in type 1 diabetes, but US FDA questions the size of the clinical benefit and the magnitude of a diabetic ketoacidosis risk.
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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.
Companies are supporting new US-labeled indication for cardiovascular mortality risk reduction with a consumer education campaign, direct-to-consumer advertising and cardiologist detailing.
The 12-11 vote supporting new indication for reduced incidence of cardiovascular death provides cover for FDA if it decides more data are needed before granting first CV benefit claim to a diabetes drug.