The FDA published the briefing docs today for their Advisory Committee meeting on the new drug application for degludec. Traders may not like their odds after reviewing the document. It's available via a link on NVO's website. The meeting is this Thursday, Nov. 8th.
From news-wire: Reuters reported that the United States (US) drug reviewers flagged a notable but uncertain cardiovascular risk associated with Novo Nordisk A/S' new ultra long-acting insulin degludec. 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% relative to comparators. A later updated analysis put the increased risk at 30%. In both cases, however, the statistical uncertainty was large. Staff from the US 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 November 8, 2012. The FDA will make a final decision later, taking into account the advisers' recommendations.
Maybe a tea partier thinking the election will not go his way, and figuring the Affordable Care Act will hurt health care stocks? Or just someone who needs out - an insurer with heavy losses from Sandy? I don't know....
Insulin acting longterm at the insulin receptor (such as glargine and detemir) does not cause cardiovascular events like this. The confidence interval includes no effect and even a bit into the protective range. So it is not significant, it is a trend, and it will be resolved in a postmarketing studies. Degludec will be on the market soon in Europe and Japan, so there will be a lot of data without the expense of another clinical trial. This "signal" is like that of byetta and pancreatitis- just a false alarm due to higher background risk in the diabetes population. Maybe the FDA should approve for type 1 DM first, since at least those T1DM without proteinuria have less background risk.