Novo Nordisk has asked the FDA and the European Medicines Agency (EMA) permission to market Fiasp, its “mealtime insulin,” for use in children and adolescents with type 1 diabetes. In 2017, the fast-acting insulin was approved by the FDA for use by adults with diabetes.
The firm submitted for the label change after reporting favorable results of a Phase III trial involving 777 children and adolescents with type 1 diabetes. In that trial, participants either bolused with Fiasp or conventional fast-acting insulin aspart over a 26-week period. Researchers found that those participants who bolused with Fiasp at mealtime experienced improved HbA1c scores and better blood sugar levels an hour after meal times than those who used the conventional fast-acting insulin aspart.
No timetable is given by FDA or EMA regulators for a decision on such applications.
To read Novo Nordisk’s press release, click here.
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