MannKind Shares Game Plan For Tackling Afrezza's Complete Response
This article was originally published in The Pink Sheet Daily
Execs fend off criticism for taking so long to release complete response letter news, and share plan to adapt ongoing trials to meet new FDA demands. But some analysts are not convinced.
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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.
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.
With two new positive Phase III studies, MannKind is getting back on regulatory track, with plans for a new FDA filing of Afrezza in the fourth quarter. Still, the firm is planning more Phase IIIb/Phase IV studies to differentiate the inhaled insulin on the market.