DOW JONES NEWSWIRES
Novo Nordisk said early Friday that the Endocrinologic and
Metabolic Drugs Advisory Committee of the US FDA has finalised its
discussions of questions related to liraglutide, its once-daily
human GLP-1 analogue.
MAIN FACTS:
- 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.
- 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.
- The 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", says Mads Krogsgaard Thomsen, executive vice
president and chief science officer of Novo Nordisk.
- "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".
- 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 1Q 2009.
-By Stockholm Bureau, Dow Jones Newswires; +46-8-5451-3090;
djnews.stockholm@dowjones.com