UPDATE: FDA Panel Splits On Diabetes Drug Liraglutide
April 02 2009 - 5:31PM
Dow Jones News
A Food and Drug Administration panel split on whether it thought
the agency should approve liraglutide, a proposed diabetes drug
from Novo Nordisk Inc. (NVO).
The panel voted 6 to 6 with one abstention on whether data on a
certain type of thyroid tumors seen in rodent studies permitted
marketing of the product. However, the panel said a small number of
a common type of thyroid tumor found in humans in clinical studies
were likely found because study investigators were looking for
thyroid problems, and 12 panel members said that alone shouldn't
stop marketing of the drug. One person abstained from voting.
Mary Parks, the director of FDA's division of metabolism and
endocrinology products, said the agency faced a "difficult task" in
deciding whether to approve the product given the panel's divergent
votes.
Earlier, most panel members said the product wasn't linked to an
excess in heart attacks and strokes, a key concern the FDA has with
diabetes drugs.
Specifically, the panel voted 8 to 5 on a question that asked
whether the liraglutide data was enough to rule out an
"unacceptable excess cardiovascular risk relative to
competitors."
Liraglutide is Novo Nordisk's most important drug in
development. It belongs to the same class of drugs as Byetta, which
is sold by Eli Lilly & Co. (LLY) and Amylin Pharmaceuticals
Inc. (AMLN).
The FDA said it saw a low cardiovascular event rate in clinical
studies of liraglutide but raised concerns about a small number of
patients who developed a type of thyroid cancer during clinical
studies as well as tumors that were seen in animal studies. The
agency said it didn't have data to "dismiss" the relevance of the
rodent studies relative to humans.
Shares of Novo Nordisk fell 4.3% to $47.92 during the regular
NYSE session Thursday and were at $47.20 in recent late
trading.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com