FDA staff highlight heart risk with Novo insulin
Nov 6 (Reuters) - U.S. drug reviewers flagged a notable but uncertain cardiovascular risk associated with Novo Nordisk's new ultra long-acting insulin degludec, according to documents posted online on Tuesday.
An initial assessment based on a pooled analysis of 16 clinical studies suggested it could increase the risk of cardiovascular death, non-fatal heart attack, non-fatal stroke and unstable angina by 10 percent relative to comparators.
A later updated analysis put the increased risk at 30 percent.
In both cases, however, the statistical uncertainty was large.
Staff from the U.S. Food and Drug Administration (FDA) released their review ahead of an advisory committee of outside experts, which will vote on whether to recommend the drug on Nov. 8.
The FDA will make a final decision later, taking into account the advisers' recommendations.
Novo is the world's largest insulin maker and any setback for degludec, which the Danish company plans to market under the brand name Tresiba, would be good news for rivals Sanofi and Eli Lilly.