U.S. Regulators Refuse Approval of Long-Acting Insulin Drug Tresiba

U.S. regulators recently refused to approve a new long-acting insulin drug known as Tresiba, until further tests for potential heart risks are conducted.

Novo Nordisk, the maker of the drug, is the world's leading insulin maker and the most valuable company in the Nordic region. However, it slumped to 12.5 percent as it said the decision would make it harder to meet long-term financial targets. Rival insulin producer Sanofi rose 4.5 percent according to Yahoo Health News. 

Shares of Novo have tumbled after the Danish drug maker requested more data before they can finish their review of the insulin products.

As type 2 diabetes is a world epidemic tied to over-eating and lack of exercise, with the problem comes a demand for new treatments. Novo has benefited more than any other company because of its focus on this disease, but is now significantly suffering from the recent news. 

Novo said the U.S. Food and Drug Administration (FDA) had requested additional data from an experiment focused on cardiovascular effects before it would consider approving Tresiba or related product Ryzodeg.

"It is a really bad situation," said Sydbank analyst Soren Hansen, who expects a delay of two or three years according to Reuters.

Tim Anderson of Bernstein said that the best to hope for if all goes according to plan is that the drug will come out some time in 2015, assuming there are no trial errors and with the FDA's approval.

However, he added that waiting for all the data could delay approval to 2017 or 2018, and if the study showed new risks, the timeline could be longer or never.