FDA approves rapid-acting insulin for children with diabetes
The FDA on Monday approved fast-acting insulin aspart 100 U/mL as a mealtime insulin for children with diabetes, according to a press release from Novo Nordisk.
Fast-acting insulin aspart (Fiasp) is the first and only fast-acting mealtime insulin injection that does not have a premeal dosing recommendation, according to Novo Nordisk. It is available in three dosing options: multiple daily injections, continuous subcutaneous insulin infusion pumps and IV infusion under supervision by a health care professional.
The FDA approved insulin aspart in 2017 for use by IV infusion under supervision by a health care professional or by subcutaneous multiple daily injections among adults with diabetes. The insulin aspart injection was a new formulation of NovoLog that includes niacinamide, which helps increase the speed of insulin absorption. The therapy was designed to mimic the natural physiologic insulin response that occurs after meals.
“As a parent of a son living with type 1 diabetes, I know firsthand how tough it can be to address the inevitable blood sugar spikes around mealtimes,” Todd Hobbs, MD, vice president and U.S. chief medical officer of Novo Nordisk, said in the release. “Children can be unpredictable and having the option of a fast-acting insulin that doesn’t require premeal dosing like Fiasp is a welcome development for the diabetes community.”
The approval is based on the FDA’s review of data from the onset-7 clinical trial, which confirmed the efficacy and safety of fast-acting insulin aspart in children.
As Healio previously reported, the FDA expanded the indication for insulin aspart injection 100 U/mL in October to include use in insulin infusion pumps for the improvement of glycemic response in adults with type 1 and type 2 diabetes. – by Regina Schaffer
Disclosure: Hobbs is vice president and U.S. chief medical officer of Novo Nordisk.