How Afrezza’s Labeling Stacks Up To NovoLog and Exubera
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.
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Novo Nordisk appears not to be worried about any market impact from Afrezza, MannKind’s recently approved inhalable insulin. In an exclusive interview in Copenhagen, the Danish company’s leadership told PharmAsia News that it had taken sufficient steps to maintain its stronghold on the global insulin market.
FDA’s unusually specific request suggests continued worries about safety of MannKind’s inhalable insulin; large trial (8,000-10,000 type 2 diabetics) has a variety of goals.
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.