Ghosts of Exubera Haunt Afrezza As Lung Function, Cancer Concerns Weigh Heavily
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.
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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.
Firm now faces the commercial gauntlet of establishing an inhaled insulin in the crowded diabetes market.
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.