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Afrezza Review Shows Need For Patient-Driven Endpoints In Diabetes

 
• By Sue Sutter

Hemoglobin A1c levels are not particularly meaningful to patients more interested in heading off a hypoglycemia event, FDA advisory committee’s patient representative says. Panel votes to approve MannKind’s inhaled insulin despite agency’s efficacy questions and view that a hypoglycemia benefit was not shown.

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee review of MannKind Corp.’s inhaled insulin Afrezza not only appeared to move the long-delayed product closer to approval, it shined a light on the need for better patient-driven endpoints in diabetes drug development.

While the sponsor and its supporters repeatedly trumpeted the reduced hypoglycemia associated with Afrezza (Technosphere insulin inhalation system) in the...

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More from North America

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• By Mandy Jackson and Joseph Haas

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• By Sue Sutter

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