Novo Nordisk Wins FDA Approval for Mealtime Insulin Treatment for Children


Pediatric diabetes patients have a new insulin option following a new indication approval of Fiasp (insulin aspart injection) as a new mealtime insulin option for children.

On Monday, the U.S. Food and Drug Administration (FDA) approved the Novo Nordisk-made drug for use in children. The company said Fiasp is the “first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation.” With the latest approval, Fiasp has been approved for children and adults in three different dosing options: multiple daily injections (MDI), continuous subcutaneous insulin infusion pumps and intravenous infusion under supervision by a healthcare professional.

Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk, said it can be difficult for parents of children with diabetes to manage the “inevitable blood sugar spikes around mealtimes.” Hobbs, who is diabetic, also has a son with type 1 diabetes and is well-aware of the difficulties of managing blood sugar.

“Children can be unpredictable and having the option of a fast-acting insulin that doesn’t require pre-meal dosing like Fiasp is a welcome development for the diabetes community,” Hobbs said in a statement.

Each year, there are approximately 18,000 cases of type 1 diabetes diagnosed annually. Managing diabetes can be challenging for parents and caregivers given it is hard to know exactly how much or how quickly their children will eat, making mealtime insulin dosing difficult. Conventional rapid-acting insulins must be administered ahead of meals, which requires some guesswork to dose properly, and children living with diabetes may not achieve adequate blood sugar control, Novo Nordisk said in its announcement.

Fiasp won approval based on data from the onset 7 clinical trial, which confirmed the safety and efficacy of the medication in children. The 26-week trial includes 777 children with type 1 diabetes. Fiasp is administered at the beginning of a meal or within 20 minutes after starting a meal.

For Novo Nordisk, the newest indication for Fiasp comes about a week after the company launched its My$99Insulin Program. The program is aimed at ensuring diabetic patients will have access to insulin. The financial program comes on the heels of intense criticism aimed at insulin manufacturers, particularly Novo Nordisk, Eli Lilly and Sanofi, over the rising costs of the life-saving medication. Last year, a cost analysis of insulin prices showed the price of insulin doubled between 2012 and 2016. According to the report, an individual with Type 1 diabetes paid on average $2,864 for insulin in 2012 but that jumped to $5.705 by 2016. With numerous stories of rationing of insulin due to cost concerns, members of Congress lashed out at the drugmakers at the end of 2019 over the costs. As the 2020 election nears, the price of insulin and other life-saving drugs will certainly become a campaign issue.

In November, the U.S. Food and Drug Administration announced new draft guidance to facilitate the development of low-cost insulin products. The agency said its recommendations “may result in a more efficient development program that could ultimately bring biosimilar or interchangeable insulin products to the market more quickly.”

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