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.
Accelerated Approval Program web page links to searchable databases for accelerated approvals of infectious disease products, vaccines, and other nonmalignant indications. New databases, which include products that converted to regular approval or were withdrawn, are modeled after Oncology Center of Excellence’s cancer drug databases that debuted in 2021.