Novo Nordisk says FDA may delay Liraglutide ruling
STOCKHOLM, Sept 5 |
STOCKHOLM, Sept 5 (Reuters) - Danish pharmaceuticals group Novo Nordisk (NOVOb.CO) said on Friday an assessment by the U.S. Food and Drug Administration of its type 2 diabetes drug Liraglutide is likely to be delayed by some two months.
Novo Nordisk filed for European and U.S. approval of Liraglutide in May and the firm has previously said it expected approval from the FDA in March next year.
"The agency has indicated that it will most likely have to extend the date of completing their assessment by a couple of months," the firm said in a statement.
Liraglutide is one of a class of new drugs known as incretin mimetics that are designed to induce the same effects as a blood sugar-improving hormone called GLP-1. The drug is expected to compete with Amylin Pharmaceuticals Inc's (AMLN.O) Byetta.
Shares in Novo Nordisk were down 3.5 percent at 274.50 Dansih crowns at 1537 GMT. (Reporting by Stockholm newsroom; Editing by Greg Mahlich)
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