Posted by Michael Wonder on 04 Mar 2019
Novo Nordisk files for a label update for Fiasp to the EMA and the FDA seeking approval for use in children and adolescents
1 March 2019 - Novo Nordisk today announced that it has submitted label updates to the EMA and the US FDA for Fiasp (fast-acting insulin aspart), 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. We anticipate a response from the EMA later this year, and from the FDA in early 2020.
