Novo Nordisk says FDA rejects application for approval of long-acting insulin products

NEW YORK, N.Y. – Novo Nordisk AS says the Food and Drug Administration rejected its applications for approval of once-per-day insulin drugs to treat diabetes.

The Danish drugmaker says it received a “complete response letter” from the FDA regarding its applications for approval of Tresiba and Ryzodeg, or insulin degludec, on Friday. Such a letter indicates the agency determined the application cannot be approved in its current form.

In November, panel of federal health advisers recommended that the government approve degludec. The FDA is not required to follow the group’s advice, but it often does.

Tresiba contains long-acting insulin, and Ryzodeg contains both long- and short-acting insulins.

Diabetics either do not produce enough of the hormone insulin or do not use it efficiently, allowing excess sugar, or glucose, to accumulate in the blood.