US FDA reviewers: Potential 'credible' CV signal with Novo Nordisk degludec meds
This article was originally published in Scrip
Executive Summary
While US FDA drug reviewers said Novo Nordisk's insulin degludec and insulin degludec/insulin aspart were effective in treating Type I and Type II diabetes, the regulators said they identified a "potentially important and credible" cardiovascular (CV) safety signal, which requires further investigation.