Food and Drug Administration (FDA) has recently approved Fast-acting insulin Fiasp 100 U/mL as a mealtime insulin for children with diabetes, Novo Nordisk, Denmark, has revealed.
Novo Nordisk through a press release stated that Fast-acting insulin, Fiasp is the first and only fast-acting mealtime insulin injection that does not have a premeal dosing recommendation.
According to Todd Hobbs, MD, vice president and U.S. chief medical officer of Novo Nordisk, the FDA approval of insulin for children means that children with diabetes will have more flexibility in their mealtime insulin dosing.
It is available in three dosing options: multiple daily injections, continuous hypodermic insulin infusion pumps and IV infusion under supervision by a healthcare professional, Hobbs said.
The FDA approved insulin Fiasp in 2017 for use by IV infusion under supervision by a healthcare professional or by subcutaneous multiple daily injections among adults with diabetes.
The press statement noted that the insulin Fiasp 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.
Explaining more on the injection called Fiasp, Eliza Skoler, a biologist and an associate at the diaTribe Learn, said while many fast-acting meal-time insulin need to be dosed before a meal, Fiasp does not have a pre-meal dosing recommendation.
She added that Fiasp can be taken before, at the beginning, or even within 20 minutes of starting a meal.
“This flexibility is due to the faster onset and offset of this insulin. It is still strongly recommended that users take Fiasp before the start of the meal when possible, but the option to take it up to 20 minutes later does add extra flexibility when necessary in other to manage their blood glucose levels more effectively,” She said.
“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,” Hobbs, 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 Fiasp in children.
According to Hobbs, the FDA expanded the indication for insulin Fiasp injection 100 U/mL in October 2019 to include use in insulin infusion pumps for the improvement of glycemic response in adults with type 1 and type 2 diabetes.