International plans
Castagna: We filed in Brazil. We will
file by ourselves in some markets like Canada. And we'll evaluate Europe and Australia. And then we'll
partner in markets like China, the Middle East, and India and Japan. And so as you look out, those are some of the ways we continue to expect to
bring in revenue and royalties in the future that will create more value for our shareholders.
Let's check the competition.
New fast-acting mealtime insulin, Fiasp®, now approved and available in Canada for the treatment of diabetes
Faster absorption of insulin key for Canadians living with diabetes
www.novonordisk.ca/content/dam/Canada/AFFILIATE/www-novonordisk-ca/News/Fiasp_Launch_PR_English.pdfMISSISSAUGA, ON,
March 27, 2017 – Today, Novo Nordisk Canada Inc. announced
that Fiasp® (insulin aspart), a faster acting mealtime insulin,is now
approved and
available in Canada, giving Canadians living with diabetes a new treatment option for
achieving optimal mealtime glucose control.1,2
Approximately 11 million Canadians live with diabetes or prediabetes and that number is
set to increase to more than 13 million by 2026.3 Diabetes can lead to serious
complications if left untreated or improperly managed, including heart attack, stroke,
kidney failure, blindness and amputation.4
Achieving optimal glycemic control is recommended by Diabetes Canada to reduce the
incidence and slow the progression of diabetes-related complications.5 Yet, limiting
postprandial (post-meal) glycemic (PPG) excursions has been one of the most
challenging aspects in achieving adequate glycemic control.6
Fiasp® is an innovative formulation of insulin aspart that more closely matches the
natural physiological insulin response of a person without diabetes, after a meal,
compared with NovoRapid® (conventional insulin aspart).7 Fiasp® also has the option of a
flexible dosing regimen (up to two minutes before a meal and up to 20 minutes after
starting a meal), without compromising overall glycemic control or safety.1,8
“People living with diabetes often struggle to control blood glucose around mealtimes,
which can be extremely challenging and result in debilitating diabetes-related
complications,” said Dr. Rémi Rabasa-Lhoret, endocrinologist at the Institut de
Recherches Cliniques de Montréal and onset® investigator*. “With the approval of a
faster-acting insulin, one that is closer to the natural physiological insulin response of a
person without diabetes, we can further support people in managing their blood glucose
levels around meals, which may help prevent hyperglycemia, for instance, a condition
that can cause serious complications for people living with diabetes.”
Fiasp® is absorbed faster than NovoRapid® (conventional insulin aspart), appearing twice
as fast in the bloodstream after injection,8,ix which leads to improved glycemic control
after a meal.
In clinical trials, Fiasp® demonstrated improved overall glycemic control in type 1
diabetes and comparable overall glycemic control in type 2 diabetes, versus
NovoRapid®.1,x Results also showed improved mealtime glucose control in type 1 and type
2 diabetes.1,x This was achieved without a significant difference in the overall rate of
severe or confirmed hypoglycemia compared with NovoRapid®.1,x
“Novo Nordisk is committed to helping people living with diabetes better manage their
disease, and in preventing complications that could have a detrimental impact on their
health and quality of life,” said Brian Hilberdink, President, Novo Nordisk Canada Inc.
“We are continuously researching innovative solutions to improve diabetes management
and address critical unmet needs. We are pleased to be able to offer a new solution with
the launch of Fiasp®, one that supports people with diabetes in achieving optimal
mealtime glucose control, particularly in an area that is in need of more innovative
advancements.”
About Fiasp®
Fiasp® is a new, faster acting mealtime insulin, developed by Novo Nordisk with the
objective of achieving a faster initial absorption, to improve glycemic control after a
meal, in people with type 1 and type 2 diabetes.1,2 Fiasp® is insulin aspart, a molecule
with more than 17 years of clinical experience,xi in an innovative formulation, in which
two excipients have been added, Vitamin B3 (niacinamide) to increase the speed of
absorption, and a naturally occurring Amino Acid (L-Arginine) for stability.9
The efficacy and safety profile of Fiasp® was investigated in the phase 3a onset® clinical
trial program consisting of four trials, encompassing more than 2,100 people with type 1
and type 2 diabetes.
Fiasp® was approved by Health Canada on January 6, 2017 for the treatment of adult
patients with diabetes mellitus who require mealtime insulin for the control of
hyperglycemia.2
Fiasp® received marketing authorization from the European Commission
on January 9, 2017. It is currently
under regulatory review in Switzerland, Australia,
Brazil, South Africa and Argentina.
[Brazil, S Africa, Australia, Canada are also targeted by Afrezza. Fiasp was approved by EU, Can at almost the same time!
Expect Afrezza approval by Health Canada to be quick! It took almost 3 mos to make Fiasp avail in Canada since approval by Health Canada]
