FDA approves expanded indication for Novo Nordisk’s Fiasp

Novo Nordisk has received the Food and Drug Administration’s clearance for Fiasp (insulin aspart injection) 100 u/mL to include use in insulin infusion pumps for the improvement of glycemic control in adults with Type 1 or Type 2 diabetes.

Fiasp, a rapid-acting insulin, was approved by the FDA in 2017 for use by intravenous infusion under supervision by a healthcare professional or by subcutaneous multiple daily injection, or MDI in adults with diabetes.

"People living with diabetes are looking for treatment options that fit into their lifestyles and shifting schedules, and for many, an insulin pump is an important part of their regimen," said Todd Hobbs, Novo Nordisk vice president and U.S. chief medical officer.

"Since the launch of Fiasp, we've heard time and again from the diabetes community about the need to make it available for adult insulin pump users. This label update will now enable adult patients to use Fiasp in their pumps, which is an important part of our ongoing commitment to patient choice and meeting the needs of people living with Type 1 and Type 2 diabetes."

Fiasp is the first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation. Fiasp is administered at the beginning of a meal or within 20 minutes after starting a meal.