Immediate-Acting Mealtime Insulin Analog — Fiasp — Received FDA Approval

A new ultra-rapid injectable synthetic insulin has been added to Novo Nordisk's antidiabetes product line-up.

With Bruce Bode, MD, and Scott D. Isaacs, MD, FACP, FACE

Novo Nordisk received approval for Fiasp, a rapid-acting synthetic insulin analog, from the Food and Drug Administration (FDA) for type 1 and type 2 diabetes in adults. This product  was designed to provide patients with the ability to self-administer this insulin form with a meal, as needed so that they will have greater flexibility in managing their serum glucose level.1

The injectable insulin analog, whose name was derived from “faster-acting insulin aspart,” is intended to help patients better regulate their blood sugar and avoid the potential complications from a failure to achieve good glucose control,1 according to the company. The formulation is a modification of Novo Nordisk’s insulin product NovoLog. The new drug includes niacin (vitamin B3) and L-arginine, which facilitate absorption of the hormone.

Ultra-rapid injectable mealtime insulin, Fiasp, receives FDA approval.

  “According to an analysis in our FDA submission, Fiasp appeared in the bloodstream in 2.5 minutes,” said Todd Hobbs, MD, chief medical officer for diabetes of Novo Nordisk North America, in a company statement.1 “In that same analysis, NovoLog appeared in the bloodstream in 5.2 minutes. Due to its fast onset and appearance in the bloodstream, Fiasp can be dosed at the beginning of a mealtime or within 20 minutes after the start of a meal.”

Clinical Support for Rapid-Acting Formulation

Novo Nordisk initially sought FDA approval for Fiasp in December 2015 but the petition was rejected and accompanied by a request for more data on the pharmacology and immunogenicity of the formulation.

The FDA granted approval based on new findings from clinical studies of more than 2,000 adults with type 1 and type 2 diabetes.2,3 The largest of these, Onset 1, a phase 3a trial, found that people who took Fiasp experienced a 0.10% greater reduction in blood sugar than those who took conventional insulin.3 The findings indicated that Fiasp was associated with a statistically significant, albeit clinically modest, 0.91 mmol/L reduction in postprandial glucose one hour after eating. Rates of hypoglycemia were similar for both groups.3

In addition to hypoglycemia, adverse events that occurred in 5% or more of study volunteers included nasopharyngitis, upper respiratory tract infection, nausea, diarrhea, and back pain.4

Expanding Rapid-Acting Insulin Options

“The intention for this 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 hemoglobin A1C management,” said Bruce Bode, MD, FACE, president of Atlanta Diabetes Associates and associate professor at Emory University School of Medicine, in Atlanta, who was involved in the initial drug trial.3

Fiasp, which also has been approved in Europe and Canada (but not available for use in pumps), will be marketed in prefilled FlexTouch pens and 10 mL vials with 100 units per milliliter.  According to the product insert, “this medicine has its maximum effect between 1 and 3 hours after the injection and the effect lasts for 3 to 5 hours.4 This diabetes medication normally would be used in combination with intermediate-acting or long-acting insulin preparations.”

NovoRapid, another fast-acting insulin aspart formulation from Novo Nordisk, is absorbed and available within 10-20 minutes, providing people who diabetes a range of options to best control their glucose levels.

Perspectives on Use of Fiasp

Patients with diabetes have taken to Twitter to discuss their experiences with Fiasp, where it seems to be getting mixed reviews. One user, who said she has been taking the drug for six months, wrote: “I was loving it but recently it's just not right. Don't know how long to give it? Any help?” Another wrote: “I'm out! Dislike dose size and unpredictability. Worry about late hypos w/ doses that big especially at night. Humalog works just fine.” Others complained of reactions at injection sites.

 “Fiasp could appeal to patients who struggle to appropriately time their insulin dosing, said Scott D. Isaacs, MD, FACP, FACE, medical director of Atlanta Endocrine Associates, and a member of the clinical faculty of Emory University School of Medicine,

“As such, it’s giving an insulin that’s more realistic and easier to use on an everyday basis but whether and how often clinicians will prescribe [Fiasp] likely will depend on insurance coverage, red tape due to need for prior authorization and other ‘hassle factors’ that may create extensive work for physicians,’ he told EndocrineWeb, “If there’s minimal benefit clinically and a huge disadvantage financially, it will prove not worthwhile for endocrinologists to prescribe or patients to use.” 

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