Novo Nordisk has won a key vote by a European expert panel supporting its application for the diabetes drug liraglutide. The European Medicines Agency issued a positive opinion of the drug, which would be marketed as Victoza. And that news significantly buoyed Novo's shares this morning.
Provided a formal European approval follows on schedule, Novo Nordisk says that it is prepared to have the Type 2 diabetes drug on the European market by this summer. And the drug company adds that it is engaged in "constructive dialogue" with the FDA over the drug's marketing application in the U.S.
"We are in a constructive dialogue with the FDA, but whether they will take any direction from a European decision, we don't know," said Mads Krogsgaard Thomsen, chief science officer at Novo Nordisk.
Greatly complicating liraglutide's chances in the U.S. is an FDA panel review that raised doubts on the drug's safety. The panel came up with a split vote on whether thyroid tumors seen in animal studies should force a delay. Analysts say that the FDA may be persuaded to delay or prevent the drug from hitting the market.
- read the report from Reuters