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2016-11-21

Novo Nordisk A/S: Novo Nordisk receives US FDA approval for Xultophy® 100/3.6

Bagsværd, Denmark, 21 November 2016
- Novo Nordisk today announced that the US Food and Drug Administration (FDA)
has approved the New Drug Application (NDA) for Xultophy®100/3.6.
Xultophy®100/3.6 is indicated as an adjunct to diet and exercise to improve
glycaemic control in adults with type 2 diabetes mellitus inadequately
controlled on basal insulin (less than 50 units daily) or liraglutide (less
than or equal to 1.8 mg daily).

Xultophy®100/3.6, the approved brand name for IDegLira in the US, is a
once-daily, single injection fixed combination of long-acting insulin
degludec (Tresiba®) and the GLP-1 analogue liraglutide (Victoza®). In the
DUAL phase 3 clinical trial programme, Xultophy®100/3.6 consistently showed
an improvement of glycaemic control in adults with type 2 diabetes
uncontrolled on liraglutide or basal insulin therapy. For adults inadequately
controlled on insulin glargine U100, treatment with Xultophy®100/3.6
demonstrated a reduction in HbA1cof 1.7% after 26 weeks. Xultophy®100/3.6 can
be taken at the same time each day with or without food and will be available
in a prefilled pen.

"We are pleased with the approval of Xultophy®100/3.6 and look forward to
launching it in the US in the first half of 2017", said Mads Krogsgaard
Thomsen, executive vice president and chief science officer of Novo Nordisk.
"We believe Xultophy®100/3.6 offers significant benefits and is an important
and convenient treatment option especially for people not achieving
sufficient glycaemic control with basal insulin".

The approval follows the recommendation of the FDA's Endocrinologic and
Metabolic Drugs Advisory Committee (EMDAC), which voted 16-0 in favour of an
approval of Xultophy®100/3.6 for the treatment of adults with type 2
diabetes, at its meeting on 24 May 2016.

About Xultophy®100/3.6

Xultophy®100/3.6 is a once-daily, single injection fixed combination of
long-acting insulin degludec (Tresiba®) and the GLP-1 analogue liraglutide
(Victoza®). The Xultophy®100/3.6 pen delivers doses from 10 to 50 units with
each injection. Each unit of Xultophy®100/3.6 contains 1 unit of insulin
degludec and 0.036 mg of liraglutide.

Further information

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| Media: |
| Katrine Sperling +45 3079 6718 krsp@novonordisk.com |
| Ken Inchausti (US) +1 609 786 8316 kiau@novonordisk.com |
| Investors: |
| Peter Hugreffe Ankersen +45 3075 9085 phak@novonordisk.com |
| Melanie Raouzeos +45 3075 3479 mrz@novonordisk.com |
| Hanna Ögren +45 3079 8519 haoe@novonordisk.com |
| Anders Mikkelsen +45 3079 4461 armk@novonordisk.com |
| Kasper Veje (US) +1 609 235 8567 kpvj@novonordisk.com |
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Company announcement No 82 / 2016

PR161121_Xultophy_FDA_UK
http://hugin.info/2013/R/2058006/771201.pdf

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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

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