FDA approves fast-acting mealtime insulin
The FDA today approved Novo Nordisk’s insulin aspart injection, a fast-acting mealtime insulin to improve glycemic control in adults with type 1 and type 2 diabetes, according to a company press release.
The insulin aspart injection, Fiasp, is a new formulation of NovoLog that includes niacinamide, which helps increase the speed of insulin absorption. The injection should be administered before a meal or within 20 minutes of finishing a meal.
“With Fiasp, we’ve built on the insulin aspart molecule to create a new treatment option to help patients meet their post-meal blood sugar target,” Bruce Bode, MD, FACE, president of Atlanta Diabetes Associates and associate professor at Emory University School of Medicine, said in the release. “The intention of rapid-acting insulin therapy is to mimic, as much as possible, the natural physiological insulin response that occurs after meals, a process that is important for optimal HbA1c management.”
Approval for the injection was based on results from a phase 3a clinical development program in which more than 2,000 adults with type 1 and type 2 diabetes were enrolled to evaluate the safety and efficacy of the fast-acting insulin administered at mealtime and after starting a meal. HbA1c was effectively reduced with the fast-acting insulin, according to the company. Nasopharyngitis, upper respiratory tract infection, nausea, diarrhea and back pain were common adverse reactions.
The injection will be available in a prefilled delivery device and a 10-mL vial.