FDA: No Decision On CV Outcomes Trial For Afrezza
Despite the apparent lack of a cardiovascular safety signal in the inhaled insulin’s clinical program, agency says the question of whether a dedicated study would be required post-approval “is still under discussion.”
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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.
FDA is requesting data from a dedicated cardiovascular outcomes trial before approving the ultra-long-acting insulins Tresiba and Ryzodeg. News of the regulatory setback caused a 13% drop in the company’s stock price on Feb. 11.