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 clinical development program, FDA said it found no clear, consistent...