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Latest From Michael Cipriano
Pink Sheet Podcast: The Upcoming US FDA Commissioner Confirmation Hearing, Sublocade Loses Orphan Designation, Project Orbis Politics
The latest news about products accepted into US FDA expedited review programs.
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The latest news on US FDA user fee decisions and submissions to the agency.
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.
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.