EU Granted Extension of the Indication for Novo Nordisk Fiasp®

| By | diabetes, European Commission, Novo Nordisk

Novo Nordisk announced that the European Commission has granted an extension of the indication for Fiasp® (fast-acting insulin aspart), approving it for the treatment of diabetes in adolescents and children (aged one year and above). This complements the previous indication, which covered adults only.

“We are very pleased with the decision of the European Commission to expand the indication of Fiasp®, making it available within this younger population,”

said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.

“With this expanded indication, we hope that adolescents and children who are at least one year old will find in Fiasp®a good option in the management of their diabetes.”

For this pediatric population, it is recommended that Fiasp® is administered prior to the meal (0-2 minutes before the start of the meal). However, Fiasp®can also be administered up to 20 minutes after the start of a meal (post-meal dosing) in situations when there is uncertainty about the meal intake. Close monitoring of blood sugar levels is advised when dosing Fiasp® post-meal at dinner time to avoid nocturnal hypoglycaemia (low blood sugar levels).

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