Novo Nordisk's new fast-acting mealtime insulin Fiasp® approved in the US
(Thomson Reuters ONE) -
Bagsværd, Denmark, 29 September 2017 - Novo Nordisk today announced that the US
Food and Drug Administration (FDA) has approved Fiasp(®) (fast-acting insulin
aspart), a new fast-acting mealtime insulin, for the treatment of adults with
diabetes. The FDA's decision comes after Fiasp(®) in clinical trials
demonstrated benefits for people in need of improved overall glucose control.
Fiasp(®) is an innovative formulation of insulin aspart (NovoLog(®)) developed
with the aim of obtaining pharmacokinetic and pharmacodynamic properties that
more closely match the natural physiological insulin mealtime response of a
person without diabetes.
In clinical trials Fiasp(®) has demonstrated clinically relevant improvement in
long-term glucose level (HbA(1c)). These results were achieved with a comparable
overall rate of severe or blood-sugar confirmed hypoglycaemia, between Fiasp(®)
and insulin aspart.
"We are very pleased that Fiasp(®) will now also be available to people with
diabetes in the US," said Mads Krogsgaard Thomsen, executive vice president and
chief science officer of Novo Nordisk. "The fast action profile of Fiasp(®)
allows people with diabetes convenient timing in terms of when to take their
insulin in connection with meals to achieve the optimal blood sugar control."
About Fiasp(®)
Fiasp(®) is insulin aspart 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. The review of
Fiasp(®) was based on the 'onset' programme, a phase 3 clinical programme
comprising four trials encompassing more than 2,100 people with type 1 and type
2 diabetes.
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 41,400 people in
77 countries and markets its products in more than 165 countries. Novo Nordisk's
B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the
New York Stock Exchange (NVO). For more information, visit novonordisk.com,
Facebook, Twitter, LinkedIn, YouTube
Further information
Media:
Katrine Sperling +45 4442 6718 krsp(at)novonordisk.com
Ken Inchausti (US) +1 609 786 8316 kiau(at)novonordisk.com
Investors:
Peter Hugreffe Ankersen +45 3075 9085 phak(at)novonordisk.com
Hanna Ögren +45 3079 8519 haoe(at)novonordisk.com
Anders Mikkelsen +45 3079 4461 armk(at)novonordisk.com
Christina Kjær +45 3079 3009 cnje(at)novonordisk.com
Kasper Veje (US) +1 609 235 8567 kpvj(at)novonordisk.com
Company Announcement No 74 / 2017
Company Announcement No 74 / 2017:
http://hugin.info/2013/R/2138112/818474.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novo Nordisk A/S via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 29.09.2017 - 16:10 Uhr
Sprache: Deutsch
News-ID 561929
Anzahl Zeichen: 3797
contact information:
Town:
Bagsvaerd
Kategorie:
Business News
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