FDA Panel:No Evidence Novo Diabetes Drug Raises Heart Risks
April 02 2009 - 3:11PM
Dow Jones News
A Food and Drug Administration panel said Thursday that Novo
Nordisk Inc. (NVO) has provided enough evidence to show its
proposed diabetes drug liraglutide doesn't cause heart attacks and
strokes.
The panel still has to vote on questions relating to concerns
about thyroid cancer so it's not yet clear if the panel thinks the
FDA should approve the product.
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.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com