FDA approves Novo Nordisk’s Fiasp®

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Novo Nordisk has announced that the US Food and Drug Administration (FDA) has approved Fiasp® (fast-acting insulin aspart), a new fast-acting mealtime insulin, for the treatment of adults with diabetes. The FDA’s decision comes after Fiasp® in clinical trials demonstrated benefits for people in need of improved overall glucose control.

Fiasp® is an innovative formulation of insulin aspart (NovoLog®) developed with the aim of obtaining pharmacokinetic and pharmacodynamic properties that more closely match the natural physiological insulin mealtime response of a person without diabetes.

In clinical trials, Fiasp® has demonstrated clinically relevant improvement in long-term glucose level (HbA1c). These results were achieved with a comparable overall rate of severe or blood-sugar confirmed hypoglycemia, between Fiasp® and insulin aspart.

“We are very pleased that Fiasp® will now also be available to people with diabetes in the US,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “The fast action profile of Fiasp® allows people with diabetes convenient timing in terms of when to take their insulin in connection with meals to achieve the optimal blood sugar control.”

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