Shares of Novo Nordisk tumbled Monday after the Danish drug maker said US regulators need a new study before they can finish their review of two diabetes treatments, a development that could delay approval for several years.
The company said Sunday that the Food and Drug Administration wants to see information from a study that looks at cardiovascular health before it makes a decision on Tresiba and Ryzodeg, which both use the long-acting insulin degludec.
Novo Nordisk said it was surprised and disappointed by the decision. The company plans to provide the requested data, but it probably will not be able to do so this year.
The request could delay US approval by up to five years, Jefferies analyst Jeffrey Holford said in a research note. European regulators approved Tresiba and Ryzodeg last month, and the drugs also have been approved in Japan and Mexico.
An expert FDA panel had voted 8 to 4 in favor of approving the drugs in November, or more than a year after Novo Nordisk submitted its application. The panelists also voted unanimously that the drug maker should be required to conduct a cardiovascular study because of concern about possible heart safety side effects.