Novo Nordisk files for regulatory approval of liraglutide in both the
US and Europe
Novo Nordisk today announced the submission of a New Drug Application
(NDA) to the Food and Drug Administration (FDA) in the US as well as
a marketing authorisation application to the European Medicines
Agency (EMEA) in Europe, for the approval of liraglutide, a
once-daily human GLP-1 analogue, for the treatment of people with
type 2 diabetes.
Both the US and the European applications contain documentation from
an extensive clinical development programme that included around
6,500 people of which approximately 4,200 received liraglutide. The
programme was designed to obtain the indication for use of
liraglutide to treat type 2 diabetes as an adjunct to diet and
exercise, both as monotherapy and in combination with commonly used
antidiabetic medications. The majority of people were included in the
phase 3 trials constituting the LEAD(TM) (Liraglutide Effect and
Action in Diabetes) programme. The LEAD(TM) programme has compared
liraglutide with three widely used classes of antidiabetic drugs -
sulfonylurea, glitazone or basal insulin - and the programme
confirmed a statistically significant benefit of liraglutide on the
primary endpoint, lowering of blood glucose (HbA1c), as well as on
the secondary endpoint, weight loss.
Mads Krogsgaard Thomsen, executive vice president and chief science
officer at Novo Nordisk, said: "This is a major achievement for Novo
Nordisk and it represents a huge amount of work done by Novo Nordisk
employees and our collaborators across the world. We are very pleased
with the results from the programme demonstrating that liraglutide
will be able to offer benefits to people with type 2 diabetes. We are
enthusiastic about the prospect of bringing liraglutide to market
after completion of the regulatory process."
Novo Nordisk still expects to file for marketing approval of
liraglutide in Japan in the third quarter of 2008.
The submission of liraglutide in the US and Europe does not impact
Novo Nordisk's expectations for the company's financial results for
2008, which were provided on 30 April in connection with the release
of the financial results for the first quarter of 2008.
About liraglutide, LEAD(TM) and HbA1c
Liraglutide is a once-daily human analogue of the naturally occurring
hormone Glucagon-Like Peptide-1 (GLP-1). Liraglutide works by
stimulating the release of insulin only when glucose levels become
too high and by inhibiting appetite. In contrast to most other
antidiabetic treatments, liraglutide also leads to weight loss
instead of weight increase.
The portfolio of LEAD(TM) studies for liraglutide included around
4,000 patients with type 2 diabetes whose blood glucose is
inadequately controlled. The programme was comprised of five
randomised, controlled, double-blind studies conducted in more than
40 countries.
* The LEAD(TM) 1 and LEAD(TM) 2 studies investigated the effect of
different doses of liraglutide in combination with a single oral
antidiabetic drug, glimepiride and metformin respectively.
* The LEAD(TM) 3 study compared the effect of liraglutide with
glimepiride when used as monotherapy.
* The LEAD(TM) 4 study investigated the effect of different doses
of liraglutide in combination with metformin and rosiglitazone.
* The LEAD(TM) 5 study compared the effect of liraglutide with
insulin glargine when used as add-on therapy in patients
inadequately controlled by two of the most widely used oral
antidiabetic drugs: metformin and a sulfonylurea (glimepiride).
* At the annual meeting of the American Diabetes Association (ADA)
to be held in San Francisco on 6-10 June 2008, Novo Nordisk will
present detailed results from the LEAD(TM) phase 3 programme with
liraglutide.
HbA1c is an abbreviation for glycated haemoglobin HbA1c. The level of
HbA1c reflects the average blood glucose level over the past two to
three months and a decrease is therefore a measure of treatment
effect. The higher the blood glucose the more glucose binds to
haemoglobin (glycation).
Novo Nordisk is a healthcare company and a world leader in diabetes
care. In addition, Novo Nordisk has a leading position within areas
such as haemostasis management, growth hormone therapy and hormone
replacement therapy. Novo Nordisk manufactures and markets
pharmaceutical products and services that make a significant
difference to patients, the medical profession and society. With
headquarters in Denmark, Novo Nordisk employs approximately 26,300
employees in 80 countries, and markets its products in 179 countries.
Novo Nordisk's B shares are listed on the stock exchanges in
Copenhagen and London. Its ADRs are listed on the New York Stock
Exchange under the symbol 'NVO'. For more information, visit
novonordisk.com.
Further information:
Media: Investors:
Outside North America: Outside North America:
Mike Rulis Mads Veggerby Lausten
Tel: (+45) 3079 3573 Tel: (+45) 4443 7919
mike@novonordisk.com mlau@novonordisk.com
Hans Rommer
Tel: (+45) 4442 4765
hrmm@novonordisk.com
In North America: In North America:
An Phan Christian Qvist Frandsen
Tel: (+1) 609 987 4893 Tel: (+1) 609 919 7937
anph@novonordisk.com cqfr@novonordisk.com
Stock Exchange Announcement no 29 / 2008