FDA questions safety of Novo Nordisk’s insulin

Hannah Blake

pharmaphorum

US regulators believe that Novo Nordisk’s new long-acting, once-a-day insulin, Tresiba, has a notable, but uncertain, cardiovascular risk.

An initial assessment, based on a pooled analysis, suggested Tresiba (degludec) could increase the risk of cardiovascular death, non-fatal heart attack, non-fatal stroke and unstable angina by 10 percent relative to comparators. However, an updated analysis put this increased risk at 30%.

The FDA now questions as to whether more safety studies should be conducted on Tresiba. While the clinical studies of the drug involved almost 9,000 patients with diabetes, the studies were not designed to look at heart risks and the FDA has expressed its concern about an imbalance of heart-related events seen in studies.

These concerns about Novo’s product were released by the FDA in advance of an advisory committee meeting on Thursday 8th November 2012. During the meeting, a panel of non-FDA medical experts will discuss the heart-related risks and will vote on whether Novo’s insulin should be approved for marketing.

The FDA will make its own decision at a later stage, taking into consideration the panel’s recommendations. The Danish pharmaceutical company believes that Tresiba will be approved, but may require a long-term cardiovascular outcomes study.

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