* US panel to consider diabetes drug on Thursday
* Novo shares fall 4.8 percent
* Company says benefits for diabetics outweigh risks
(Adds details on safety data; updates shares)
By Lisa Richwine
WASHINGTON, March 31 U.S. regulators want
outside advisers to assess heart risks from Novo Nordisk's
(NOVOb.CO) proposed diabetes drug, liraglutide, as well as
thyroid tumors in rodents, documents released on Tuesday said.
Few major cardiovascular problems were seen in studies of
liraglutide, but the small numbers limited the analysis of the
drug's safety, Food and Drug Administration reviewers said.
The shares of the Danish company fell 4.8 percent in
trading in Copenhagen. Analysts view the drug as a potential
blockbuster and key driver for Novo in the coming years.
Cardiac risks have emerged as a major concern with diabetes
drugs and the FDA has asked makers to analyze if the medicines
raise the chances of heart attacks, strokes or other problems.
Some comparisons suggested liraglutide carried a higher
cardiovascular risk than a placebo, depending upon how the data
were analyzed, FDA reviewers said. Tests against other drugs,
however, showed similar heart risks.
Studies in rats and mice given liraglutide found cases of
thryoid tumors and the FDA will ask the panel if that concern
applies to humans.
Five people treated with the drug developed a type of
thyroid tumor compared with one given a different diabetes
drug. Thyroid tumors are common in the general population and
the ones seen in liraglutide patients were "very small," the
FDA reviewers said.
"The applicability of these rat and mouse findings to
humans in not fully understood."
An FDA advisory panel of outside experts will review
liraglutide on Thursday and vote on whether there is enough
data on the heart and tumor issues to recommend approval. The
proposed brand name is Victoza.
The FDA's own staff reviewers said liraglutide was
effective at lowering blood sugar and in some cases worked
better than other medicines.
Novo Nordisk, in a separate summary prepared for the panel,
said liraglutide offered advantages that included weight loss
and once-a-day dosing unrelated to meals.
The company said the thyroid tumors were "rodent-specific"
and there was no sign they would occur in humans. Novo proposed
a large, post-approval study to further assess heart-related
Overall, the drug has a "favorable benefit/risk profile,"
Liraglutide belongs to the GLP-1 class of injectable drugs
that stimulate insulin release when glucose levels become too
high. If approved, it would provide competition for Amylin
Pharmaceuticals Inc's AMLN.O GLP-1 drug Byetta.
The FDA usually approves drugs that win endorsements from
its independent advisory panels, although the agency has
rejected or delayed some medicines recently recommended by
(Editing by Dave Zimmerman and Andre Grenon)