Novo Nordisk said today that the FDA has delayed feedback on its much-anticipated diabetes drug Victoza (liraglutide) until the fourth quarter of this year. The company had predicted a positive response from the agency by this month. "Novo Nordisk continues the constructive dialog with the FDA regarding the regulatory process for liraglutide," the company said in a statement. Novo said the feedback delay will not impact company's financial results for 2009. The drug received EMEA approval in June and is already being marketed in Europe.
- take a look at Novo's release [1]
- read the Reuters write-up [2]
Related Articles:
Novo Nordisk predicts blockbuster diabetes drug approval [3]
Liraglutide beats older diabetes drug in study [4]
Novo wins European support for liraglutide [5]
Expert panel splits vote on Novo's liraglutide [6]
Novo Nordisk releases more liraglutide data [7]
Links:
[1] http://www.fiercebiotech.com/press-releases/update-timeline-formal-feedback-liraglutide-fda
[2] http://www.reuters.com/article/rbssHealthcareNews/idUSLN8345420090923
[3] http://www.fiercebiotech.com/story/novo-nordisk-predicts-blockbuster-diabetes-drug-approval/2009-08-06
[4] http://www.fiercebiotech.com/story/liraglutide-beats-older-diabetes-drug-study/2009-06-08
[5] http://www.fiercebiotech.com/story/novo-nordisk-wins-key-european-support-liraglutide/2009-04-24
[6] http://www.fiercebiotech.com/story/expert-panel-splits-vote-novos-liraglutide/2009-04-03
[7] http://www.fiercebiotech.com/story/novo-nordisk-releases-more-liraglutide-data/2008-10-17