Is Novo Nordisk's ($NVO) big insulin hope about to be dashed? At a time when regulators are looking more closely at the heart risks of diabetes treatments, FDA staffers issued their review of the Danish company's new drug Tresiba, a.k.a. degludec, and it wasn't a sunny picture. Studies "consistently pointed to potential harm associated with the use of the insulin degludec products," agency reviewers wrote (as quoted by Bloomberg).
As Reuters' Ben Hirschler noted on Twitter this morning, Novo's stock quickly dropped by 7% on the news. Sanofi ($SNY)--which sells Lantus, the drug Tresiba aims to rival--saw its shares gain 2%. As one of Sanofi's biggest sellers, now that its blood thinners Plavix and Lovenox are off patent, Lantus could grow a lot faster in the near term without a head-to-head competitor to fight.
No doubt Novo should thank Avandia for the FDA scrutiny. After the GlaxoSmithKline ($GSK) diabetes treatment proved to be risky for some patients--increasing rates of heart attack and other cardiovascular "events," some studies found--regulators not only withdrew or restricted the drug, but said they'd be looking more closely at diabetes drugs' effects on the heart.
But it's not certain doom for Tresiba and its sister combo drug--or certain joy for Sanofi. FDA reviewers often put forth a skeptical view, highlighting the negative; after all, the companies themselves will be doing the opposite. FDA's expert panel, meeting later this week, may weigh the FDA staff's opinion and still recommend for their approval.
FDA staff has asked the advisory committee to consider whether to require more study of the safety risks, Bloomberg notes, but hasn't been asked to determine whether that study should come before the Novo products hit the market. Analysts think the vote will still go Novo's way--and that FDA will still approve the drug early next year, albeit with a requirement to study the drug further.
Special Report: Tresiba - Top diabetes drug pipelines of 2012