Afrezza Review Shows Need For Patient-Driven Endpoints In Diabetes
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.
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FDA solves citizen petition with first-of-its-kind virtual patient meeting; diabetes group now hopes trifecta of requests will make it from Commissioner’s Office to top CDER officials.
MannKind’s inhaled insulin resulted in a lesser degree of hemoglobin A1c reduction than Novo Nordisk’s insulin aspart in a pivotal study in type 1 diabetics.
FDA advisory committee review of MannKind’s inhaled insulin revisits safety issues that troubled Pfizer’s first-of-its-kind product, including a potential lung cancer risk and declines in pulmonary function.