An expert FDA panel delivered a split vote on whether the agency should approve Novo Nordisk's diabetes drug liraglutide in light of data that the drug caused thyroid tumors in rodents.
A majority of the Endocrinologic and Metabolic Drugs Advisory Committee did say that Novo provided enough cardiovascular safety evidence to rule out excess cardiovascular risk of liraglutide relative to comparators. However, only a minority thought Novo had sufficiently ruled out thyroid tumor risk based on the animal data. But the panel split over whether this lack of data should impact liraglutide's approval.
While analysts don't think the FDA will completely block liraglutide's approval, they fear the FDA may demand additional data regarding the possibility of a certain type of thyroid tumor, which would delay launch of the drug. those fears cause Novo's stock to slump this morning. The closely-watched diabetes drug--which be marketed as Victoza--is Novo's most anticipated new therapy. If approved, analysts predict the drug could reach $1.5 billion a year in sales.
"We remain convinced that liraglutide has a positive benefit:risk profile and represents an important advance for people with type 2 diabetes. We will work closely with the FDA as it completes its review of our application to address the concerns expressed by members of the Advisory Committee," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
- here's Novo's update
- read the WSJ report for more