FDA Approves New Fast-Acting Insulin, Fiasp, for Diabetes in Adults

Disclosures

September 29, 2017

The US Food and Drug Administration (FDA) has approved a new faster-acting, mealtime version of insulin aspart (Fiasp, Novo Nordisk) for the treatment of type 1 and type 2 diabetes in adults.

Fiasp (insulin aspart injection 100 units/mL) is a new formulation of the company's NovoLog, to which niacinamide (vitamin B3) has been added to help increase the speed of the initial insulin absorption. Fiasp is designed to be dosed at the beginning of a meal or within 20 minutes after starting a meal, as the insulin will appear in the blood approximately 2.5 minutes after dosing.

Fiasp will be available in a prefilled delivery device, the FlexTouch pen, and a 10-mL vial. It is not approved for use in insulin pumps in the United States.

The product was first launched in Canada in March and has been approved in the member states of the European Union.

In Canada, similar to the United States, it is not approved for use in insulin pumps but in the European Union, it is.

The EU approval of Fiasp for use in insulin pumps is based on a study comparing it with conventional insulin aspart lasting just 2 weeks, but other countries may require evidence from a longer-lasting trial, Diabetes Canada spokesperson Harpreet Bajaj, MD, MPH, a community endocrinologist in Toronto, Ontario, and a research associate at Mount Sinai Hospital, told Medscape Medical News in March.

One such study, called ONSET-5, is ongoing, comparing the efficacy and safety of faster-acting insulin aspart with NovoRapid (Novo Nordisk) over 16 weeks in adults with type 1 diabetes using insulin pumps. Novo Nordisk says ONSET-5 will complete in the third quarter of 2017 and the results will be reported at a medical meeting in 2018.

"Insulin pumps are a different ballgame; we need longer-term data to be sure," Dr Bajaj commented.

Rapid-Acting Insulins Intended to Mimic Physiologic Response

"With Fiasp, we've built on the insulin aspart molecule to create a new treatment option to help patients meet their postmeal blood sugar target," said Bruce Bode, MD FACE, president of Atlanta Diabetes Associates and associate professor at Emory University School of Medicine, Atlanta, Georgia, in a Novo Nordisk press 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 A1c management."

The approval of Fiasp is based on results from the ONSET phase 3a clinical development program, which enrolled more than 2000 adults with type 1 and type 2 diabetes and showed efficacy and safety of Fiasp, administered both at mealtimes and after starting a meal.

The new product will launch at the same list price as NovoLog and will be offered with a savings card program for eligible patients with commercial insurance to reduce copays, the company says.

It will also be available to eligible patients through the Novo Nordisk patient-assistance program. Patients and caregivers can obtain more information and access to the Novo Nordisk patient assistance program by calling toll free at 866-310-7549.

Other "ultrafast"-acting insulins are in development, including Ultra-Rapid BioChaperone Lispro (Adocia), a newly formulated version of insulin lispro.

Follow Lisa Nainggolan on Twitter: @lisanainggolan1 . For more diabetes and endocrinology news, follow us on Twitter and on Facebook .

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