Fiasp(R) a New Ultra-Fast Acting Mealtime Insulin Is Available for the Treatment of Diabetes in Adults

PR67948

BAGSVAERD, Denmark, Mar. 27 /PRNewswire=KYODO JBN/--

    - Canada first country to launch Fiasp(R)

    - This material is intended for global medical media only.

    - For journalistic assessment and preparation before publication.

    Today, Novo Nordisk announced that Fiasp(R), a new, fast-acting mealtime

insulin for the treatment of diabetes in adults, has been launched in Canada,

following the recent marketing authorisation from Health Canada on 6 January

2017.

    Fiasp(R) is insulin aspart in an innovative formulation that more closely

matches the natural physiological insulin response of a person without diabetes

after a meal, compared with NovoRapid(R) (conventional insulin aspart)[1].

Fiasp(R) also has the option of a flexible dosing regimen (up to 20 minutes

after starting a meal), without compromising overall glycaemic control, when

compared to NovoRapid(R) dosed at mealtime [2],[3].

    "The launch of Fiasp(R) in Canada represents the first new mealtime insulin

in 10 years. We hope to make this innovation available to as many people with

diabetes as possible worldwide," said Mads Krogsgaard Thomsen, executive vice

president and chief science officer of Novo Nordisk. "The goal of any insulin

treatment is to match the natural physiological insulin production we see in

people without diabetes, both in speed and glycaemic control. Fiasp(R) has

narrowed the existing gap, getting us closer to that

goal."

    Fiasp(R) is absorbed faster than NovoRapid(R), appearing twice as fast in

the bloodstream after injection[1],[3], which leads to improved glycaemic

control after a meal [2],[4]. In clinical trials, Fiasp(R) demonstrated

improved overall glycaemic control in type 1 diabetes[2] and comparable overall

glycaemic control in type 2 diabetes[4], versus NovoRapid(R). Results also

showed improved mealtime glucose control in type 1 and type 2 diabetes[2],[4].

This was achieved without a significant difference in the overall rate of

severe or confirmed hypoglycaemia, compared with NovoRapid(R)[2],[4].

    Clinical trial results showed that the faster absorption of Fiasp(R),

compared to NovoRapid(R), was even more pronounced in those using a continuous

subcutaneous insulin infusion (CSII) system (insulin pump therapy)[5]. In

addition, when compared with NovoRapid(R) in a CSII setting in people with type

1 diabetes, Fiasp(R) showed no difference in pump compatibility as assessed by

microscopically confirmed infusion-set occlusions, and the treatments were

equally effective in controlling glucose levels,

compared to NovoRapid(R)[*],[*],[6].

    "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 Remi Rabasa-Lhoret, endocrinologist at

the Institut de Recherches Cliniques de Montreal and onset 1 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 hyperglycaemia, for instance, a condition

that can cause serious complications for people living with diabetes."

    Following the first country launch in Canada, Fiasp(R) will also be

available in a number of European markets in the coming months.

    About Fiasp(R)[**]

    Fiasp(R) (fast-acting insulin aspart) is a new, ultra-fast

acting[2],[7],[8] mealtime insulin, developed by Novo Nordisk with the

objective of achieving a faster initial absorption, to improve glycaemic

control after a meal, in people with type 1 and type 2 diabetes. Fiasp(R) is

insulin aspart, a molecule with more than 17 years of clinical experience[9],

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[1].

    The efficacy and safety profile of Fiasp(R) was investigated in the phase

3a 'onset' clinical trial programme consisting of four trials, encompassing

more than 2,100 people with type 1 and type 2 diabetes.

    Fiasp(R) received marketing authorisation from the European Commission on 9

January 2017, covering all 28 European Union member states; approval was also

obtained in Norway and Iceland. It is currently under regulatory review in

Australia, Switzerland, Brazil, South Africa, Argentina and Israel.

    In October 2016, a Complete Response Letter (CRL) was received from the US

Food and Drug Administration (FDA) regarding the New Drug Application for

fast-acting insulin aspart. Following an evaluation of the CRL, and ongoing

discussions with the FDA, Novo Nordisk announced as part of the 2016 full-year

results in February 2017 that a class II re-submission for fast-acting insulin

aspart was expected within the next three months.

    About Novo Nordisk  

    Novo Nordisk is a global healthcare company with more than 90 years of

innovation and leadership in diabetes care. This heritage has given us

experience and capabilities that also enable us to help people defeat other

serious chronic conditions: haemophilia, growth disorders and obesity.

Headquartered in Denmark, Novo Nordisk employs approximately 42,000

people in 77 countries and markets its products in more than 165 countries. For

more information, visit: novonordisk.com [http://www.novonordisk.com ],

Facebook [http://www.facebook.com/novonordisk ],

Twitter [http://www.twitter.com/novonordisk ],

LinkedIn [http://www.linkedin.com/company/novo-nordisk ],

YouTube [http://www.Youtube.com/novonordisk ]

References  

    1.  Heise T, et al. A pooled analysis of clinical pharmacology trials

investigating the pharmacokinetic and pharmacodynamic characteristics of

fast-acting insulin aspart in adults with type 1 diabetes. Clinical

Pharmacokinetics 2017; doi:10.1007/s40262-017-0514-8.

    2.  Russell-Jones D, et al. Double-blind mealtime faster-acting insulin

aspart improves glycaemic control with superior reduction in postprandial

glucose excursions vs insulin aspart in type 1 diabetes: onset(R) 1.

Diabetologia 2016; 59(Suppl. 1):S1-S581.

    3.  Fiasp(R) EMA Summary of Product Characteristics. Bagsvaerd, Denmark:

Novo Nordisk A/S.

    4.  Bowering K, et al. Faster-acting insulin aspart vs insulin aspart as

part of basal-bolus therapy improves postprandial glycaemic control in

uncontrolled type 2 diabetes: the onset(R) 2 trial. Diabetologia 2016;

59(Suppl. 1):S1-S581.

    5.  Heise T, et al. Pharmacological properties of faster-acting

insulin aspart vs insulin aspart in patients with type 1 diabetes receiving

continuous subcutaneous insulin infusion: A randomized, double-blind,

crossover trial. Diabetes, Obesity & Metabolism 2017; 19(2):208-215.

    6.  Zijlstra E, et al. Compatibility and safety of faster-acting insulin

aspart used in continuous subcutaneous insulin infusion therapy in patients

with type 1 diabetes. Endocrine Review 2016; 37(Suppl. 2):abstract FRI-697.

    7.  Heinemann L and Muchmore DB. Ultrafast-acting insulins: state of the

art. Journal of Diabetes Science and Technology 2012; 6(4):728-742.

    8.  Cengiz E, et al. Moving toward the ideal insulin for insulin pumps.

Expert Review of Medical Devices 2016; 13(1):57-69.

    9.  NovoRapid(R) EMA Summary of Product Characteristics. Bagsvaerd,

Denmark: Novo Nordisk A/S.

    Black Triangle Drug: This medicine is subject to additional monitoring.

Healthcare professionals and patients should report any suspected adverse

events due to use of this medicinal product.

    [*] Fiasp(R) has been approved by the European Commission for CSII (insulin

pump) use.

    [*] Fiasp(R) is not approved for insulin pump use in Canada.

    [**] Information provided about Fiasp(R) is based on the marketing

authorisation received from the European Commission and these details may vary

in individual markets.    

    Further information

    Media:         

    Katrine Sperling

    +45-3079-6718

    krsp@novonordisk.com;

    Asa Josefsson

    +45-3079-7708

    aajf@novonordisk.com

    Investors:         

    Peter Hugreffe Ankersen

    +45-3075-9085

    phak@novonordisk.com;

    Hanna Ogren

    +45-3079-8519

    haoe@novonordisk.com;

    Anders Mikkelsen

    +45-3079-4461

    arm@novonordisk.com;

    Kasper Veje (US)

    +1-609-235-8567

    kpvj@novonordisk.com;

   (Logo: http://mma.prnewswire.com/media/482186/Novo_Nordisk_Logo.jpg )

    SOURCE: Novo Nordisk