A new faster acting formulation of insulin aspart (Fiasp, Novo Nordisk) has been launched in its first market worldwide, Canada, following approval there in January. It is indicated for the treatment of type 1 or type 2 diabetes in adults, and early indications are that the product has been priced competitively.
Fiasp consists of conventional mealtime insulin aspart (NovoRapid) but in a novel formulation, to which vitamin B3 (niacinamide) and the amino acid L-arginine have been added, which, according to Novo Nordisk, means the insulin is absorbed more quickly and therefore more closely matches the natural physiological insulin response in a person without diabetes.
This allows for a more flexible dosing regimen, up to 20 minutes after starting a meal, without compromising overall blood glucose control (when compared with NovoRapid dosed at mealtimes), the company says.
Fiasp was also approved in the member states of the European Union in January, and Novo Nordisk told Medscape Medical News it anticipates launches soon in the United Kingdom and Germany.
The company has also just, as of today, resubmitted a new drug application (NDA) for Fiasp in the United States after its first attempt was met by a complete response letter from the Food and Drug Adminstration (FDA) in October 2016.
The product is also currently under regulatory review in Australia, Switzerland, Brazil, South African, Argentina, and Israel.
Canadian Approval Doesn't Extend to Use in Insulin Pumps
One key difference between the approval for Fiasp in Canada and the European Union is that it is not licensed for use in insulin pumps in Canada, but it is in the EU countries, Diabetes Canada spokesperson Harpreet Bajaj, MD, MPH, a community endocrinologist in Toronto and a research associate at Mount Sinai Hospital, explained to Medscape Medical News.
The EU approval of Fiasp for use in insulin pumps is based on a study comparing it with conventional insulin aspart lasting 2 weeks, said Dr Bajaj, whereas Canada will require evidence from a longer-lasting trial — one such study, called ONSET-5, is ongoing, comparing the efficacy and safety of faster-acting insulin aspart with NovoRapid 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 noted.
He says he has only used Fiasp in a couple of patients so far, one with type 1 diabetes and one with type 2, but he is pleased with the results, although he stresses it is early days: "Based on the data, it looks good, and the patient preference is not to have to inject insulin before eating."
And with regard to cost, Novo Nordisk confirmed to Medscape Medical News that "Fiasp has been made available at price parity to NovoRapid" in Canada.
But for other markets, it said "the price of Fiasp…is subject to individual pricing negotiations with national authorities and is still to be determined on a case-by-case basis."
"Taking the Pressure Off" When It Comes to Mealtime Insulin
The first patient Dr Bajaj has prescribed Fiasp to is a young woman with type 1 diabetes whom he described as "very careful" and who is on insulin injections but has found it challenging to inject bolus insulin 10 to 15 minutes before a meal.
"She said that, with her family [to care for], she didn't know how she could time that perfectly, and so I said, 'We have this newer insulin that is the same insulin [aspart], but acts faster,' so she was willing to switch and see."
Dr Bajaj has since done a review with the patient and said she is doing fine, Fiasp is "controlling her sugars, and she didn't have to inject 15 minutes early and felt there was pressure taken off her shoulders."
Fiasp begins to act within 4 minutes, compared with about 9 minutes for conventional insulin aspart, and "it peaks earlier," he noted, although he still emphasizes that "we need to get more experience."
The second patient he has prescribed Fiasp for is an older type 2 diabetes patient who has just started on bolus insulin and for whom the family had concerns around mealtime insulin.
In Canada and the United States, type 2 diabetes patients on insulin tend to be on a basal (long-acting) insulin first, before bolus (fast-acting) insulin is introduced at mealtimes, Dr Bajaj explained. However, this isn't necessarily the case in Europe, where bolus insulin is often used alone in type 2 diabetes, he noted.
He adds that he doesn't yet have any feedback on his type 2 patient.
Other "ultrafast"-acting insulins are in development, including Ultra-Rapid BioChaperone Lispro (Adocia), a newly formulated version of insulin lispro.
Dr Bajaj reports research support from and/or speaker bureaus for AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck, Novo Nordisk and Sanofi, although he has not participated in any of the development programs for Fiasp.
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Medscape Medical News © 2017
Cite this: First Launch for Fiasp : 'Ultrafast' Mealtime Insulin Aspart - Medscape - Mar 29, 2017.