Novo Nordisk Announces Plans to Resubmit Rejected Insulin to the FDA

Novo Nordisk A/S announced its decision to resubmit its marketing applications for diabetes drugs Tresiba and Ryzodeg to US health regulators.

In 2013, the company submitted marketing applications to the US Food and Drug Administration (FDA) for basal insulin product Tresiba and combination therapy Ryzodeg. Even after an advisory committee voted in favor of approving the drugs, the agency rejected the drugs due to safety concerns.

Now, the company said that it expects to resubmit New Drug Applications (NDAs) for Tresiba and Ryzodeg within the next month. The application will include the prespecified interim analysis of DEVOTE, the cardiovascular outcomes trial for Tresiba initiated in October 2013. The FDA asked Novo Nordisk to conduct DEVOTE to investigate potential cardiovascular risks associated with the drug, including concerns that it might be linked to higher rates of heart attacks or strokes. While the study is not complete and Novo Nordisk is only submitting an interim analysis, the company’s team has discussed the findings with regulators, suggesting a good chance the resubmission is accepted.

The news sent the company’s share up as much as 14 percent. The company, which is the world’s top insulin maker, is now in a position to get US approval of Tresiba as soon as October or November, putting it in a position to launch the drug early next year, according to industry analysts.

Tresiba is an ultra-long-acting form of insulin known as degludec. The drug, if approved, is anticipated to generate annual sales of $2.2 billion by 2020. The company continues to focus on diabetes. Last year, Novo Nordisk announced plans for a $130 million diabetes research hub in Denmark, employing roughly 350 scientists when it opens.

Source: Novo Nordisk A/S

Last updated: 3/27/15; 10:55am EST

 

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