Victoza® Approved by FDA
After months of delay Novo Nordisk (NYSE:NVO) received word late today that the FDA approved their once daily GLP-1 Victoza®. According to a company issued press release the company expects to begin marketing Victoza in the US within weeks. Additionally the company will be hosting a conference call at 2am EST tomorrow to discuss this news.
While this is positive news for Novo, the real fight begins on March 5th the PUDFA date for the once-a-week version of Byetta from Amylin (NASDAQ:AMLN) and Lilly (NYSE:LLY). By all indications Diabetic Investor expects Byetta LAR to be approved which sets up an interesting marketing battle. As Diabetic Investor has previously reported this approval could prove to be a hallow victory for Novo as based on numerous physician interviews the once-weekly version of Byetta is preferred to the once-daily Victoza®.
Victoza® is not without some advantages over LAR, however as previously reported these advantages do not offset LAR’s major advantage of once-weekly dosing. The reality here is that Novo has a limited window of opportunity to establish Victoza® in the US as everyone knows that LAR is right around the corner.
The bottom line here is simple; once-a-week dosing trumps once-a-day dosing and yes it really is that simple.