FDA Panel:No Evidence Novo Diabetes Drug Raises Heart Risks

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; [e-mail]