FDA Sets Up Afrezza Panel To Split Between Type 1 And 2 Diabetes
This article was originally published in The Pink Sheet Daily
Agency briefing documents for April 1 meeting suggest greater efficacy concerns in type 1 diabetics, although review of most recent trial in type 2 patients cites “surprisingly modest” treatment effects compared to other drugs. Safety issues for panel consideration include pulmonary function effects and lung cancer.
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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.
Inhaled insulin gains advisory committee endorsement in both type 1 and 2 populations. Given efficacy questions and potential safety concerns, panelists suggest patients who would most benefit include those with limited ability to self-inject and who need additional glycemic control in between meals.