FDA Asks for Additional Data from New Study on Cardiovascular Health
The US `Food and Drug Administration' has called the Danish drugmaker, Novo Nordisk, to provide it with information from a new study. They same has been demanded before they finish with the review of two treatments for diabetes and long-acting insulin.
The report finds that the same has resulted in plummet of shares of the world's biggest insulin maker. Novo Nordisk announced about the U. S. regulators' request on Sunday.
It has been told that they require information from the study that has been focusing at cardiovascular health. Following the same, a decision on Tresiba and Ryzodeg would be taken by the drug regulators.
However, the authorities' decision to carry out additional trials on Tresiba, long-acting insulin, would not affect the Denmark's company's plans for the drug in Japan and Europe. The company has affirmed that even the pricing would not be affected by the same.
But, the delay in the approval of the drugs would cause the company difficulties in achieving its financial long term targets, the report said.
"We have a significant delay in the U. S. launch of Tresiba that will of course, everything else being equal, make the achievement of the long-term financial targets somewhat more challenging", affirmed Jesper Brandgaard, Chief Financial Officer.
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