Novo Nordisk Files For Label Update For Fiasp To EMA, FDA - Quick Facts

(RTTNews) - Danish healthcare company Novo Nordisk A/S (NVO) announced Friday that it recently submitted label updates to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for insulin aspart injection Fiasp 100 u/mL, seeking approval for use as a new mealtime insulin for children and adolescents with type 1 diabetes.

The submissions are based on the results from the onset 7 trial which investigated the efficacy and safety of Fiasp compared with conventional insulin aspart in children and adolescents with type 1 diabetes.

The company anticipates a response from the EMA later this year, and from the FDA in early 2020. Fiasp is currently approved to control high blood sugar in adults with diabetes.