Insulin Degludec’s CV Risks Can Be Studied Post-Approval, Cmte. Says
This article was originally published in The Pink Sheet Daily
The majority of FDA’s Endocrinologic and Metabolic Drugs Advisory Committee agrees the potential advantages of Novo Nordisk’s long-acting basal insulin justify approval before a cardiovascular risk signal seen in a meta-analysis is fully explored in a dedicated outcomes study.
You may also be interested in...
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.
In briefing documents for the Nov. 8 panel review, FDA suggests the clinical trial data do not support Novo Nordisk’s assertion of a hypoglycemia advantage with its new long-acting insulin. Agency also raises concerns about a meta-analysis suggesting an increased cardiovascular risk.
US FDA received 110 designation requests in July, a high mark that reflects the 60 days needed to review such requests ahead of the 30 September statutory expiration; agency is allowing email submission of RPD and orphan drug designation requests during the COVID-19 pandemic and expects to roll out an online portal for orphan designation requests later this year.