Update on FDA Advisory Committee meeting on liraglutide for the
treatment of type 2 diabetes
Novo Nordisk today announced that the Endocrinologic and Metabolic
Drugs Advisory Committee of the United States Food and Drug
Administration (FDA) has finalised its discussions of questions
related to liraglutide, a once-daily human GLP-1 analogue.
The Advisory Committee voted on questions related to the risk profile
of liraglutide.
* A majority of Advisory Committee members supported that
appropriate evidence of cardiovascular safety had been provided to
rule out excess cardiovascular risk of liraglutide relative to
comparators.
* While a majority of Advisory Committee members did not find
that Novo Nordisk based on the available data had ruled out that
the finding of C-cell tumours in rodents was not relevant to
humans, the Advisory Committee was split on the FDA question
related to whether the available data on C-cell tumours permitted
approvability.
* Finally, the Advisory Committee unanimously supported
approvability of liraglutide with regard to risk of papillary
thyroid cancer."We remain convinced that liraglutide has a positive benefit:risk
profile and represents an important advance for people with type 2
diabetes. We will work closely with the FDA as it completes its
review of our application to address the concerns expressed by
members of the Advisory Committee," said Mads Krogsgaard Thomsen,
executive vice president and chief science officer of Novo Nordisk.
The Advisory Committee reviewed data from 40 clinical studies
involving more than 6,800 people with type 2 diabetes of which more
than 4,600 were treated with liraglutide.
The timing of US launch of liraglutide will be determined after
completion of the FDA's review of the application.
The outcome of the FDA Advisory Committee is not expected to
significantly impact Novo Nordisk's expectations for the company's
financial results for 2009, which were provided on 29 January in
connection with the release of the financial results for 2008. Novo
Nordisk will update the expectations for the company's financial
results for 2009 on 30 April 2009 in connection with the release of
the financial results for the first quarter of 2009.
FDA advisory committees are panels of independent experts who advise
the FDA as they consider regulatory decisions. The FDA is not bound
by the committee's recommendation, but it takes its advice into
consideration when reviewing new drug applications.
Conference call
On 3 April at 8am CET, corresponding to 2am EDT, a conference call
for investors will be held. Investors will be able to listen in via a
link on the investor section of novonordisk.com.
About liraglutide
Liraglutide is the first once-daily human Glucagon-Like Peptide-1
(GLP-1) analogue developed for the treatment of type 2 diabetes.
Liraglutide works by stimulating the release of insulin only when
glucose levels become too high and by inhibiting appetite. On 23 May
2008, Novo Nordisk submitted a New Drug Application to the Food and
Drug Administration in the US as well as a marketing authorisation
application to the European Medicines Agency in Europe, for the
approval of liraglutide for the treatment of people with type 2
diabetes. A New Drug Application was also submitted for approval in
Japan on 15 July 2008.
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 more than 27,000
employees in 81 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.
Contacts for further information
Media: Investors:
Mike Rulis Mads Veggerby Lausten
Tel: (+45) 4442 3573 Tel: (+45) 4443 7919
mike@novonordisk.com mlau@novonordisk.com
Kasper Roseeuw Poulsen
Tel: (+45) 4442 4471
krop@novonordisk.com
In North America: In North America:
An Phan Hans Rommer
Tel: (+1) 609 558 0420 Tel: (+1) 609 919 7937
anph@novonordisk.com hrmm@novonordisk.com
Company Announcement no 20 / 2009
