LAR clears the first hurdle

LAR clears the first hurdle

This afternoon Amylin Pharmaceuticals (NASDAQ:AMLN) announced that the FDA has accepted the NDA for the once-weekly version of Byetta. While this is not huge news it is a necessary first step. The news also comes on the heels of Novo Nordisk (NYSE:NVO) gaining European approval for their GLP-1 Victoza®. As expected the Victoza delivery device is a simple to use pen which only allows for three dosing options.

The prescribing information for Victoza contains the following information:


Few cases (<0.2%) of acute pancreatitis have been reported during long-term clinical trials with Victoza. A causal relationship between Victoza and pancreatitis can neither be established nor excluded.

Thyroid events 

The overall rates of thyroid adverse events in all intermediate and long-term trials are 33.5, 30.0 and 21.7 events per 1000 subject years of exposure for total liraglutide, placebo and total comparators; 5.4, 2.1 and 0.8 events, respectively concern serious thyroid adverse events. 

In liraglutide-treated patients, thyroid neoplasms, increased blood calcitonin and goiters are the most frequently thyroid adverse events and were reported in 0.5%, 1% and 0.8% of patients respectively.” 

While Novo is moving aggressively to market Victoza in Europe the company remains in discussions with the FDA in regards to gaining approval here in the United States. With today’s announcement it’s becoming more likely that Victoza and Byetta LAR will come to market here in the US within months of each other. While Victoza is further along than LAR, the results of the FDA panel meeting have leveled the playing field in terms of timing.  Diabetic Investor would be shocked given the current situation at the FDA combined with the results of the panel meeting if the FDA moved quickly to resolve the Victoza situation. Although no one knows for sure it would come as no surprise if the FDA asked for even more data or required an additional study to resolve the thyroid cancer issue.

Making matter worse for Novo is the recent news regarding Lantus and cancer. While no respected researcher or endocrinologists believes Lantus actually causes cancer, the FDA is obviously aware of the studies.  Given this news the FDA will likely proceed cautiously whenever there is even the smallest possibility that a drug used to treat a chronic disease such as diabetes might cause cancer. Based on all available evidence Diabetic Investor does not believe that Victoza actually causes thyroid cancer however if nothing else Novo Nordisk will be caught in the recent news cycle which is unfavorable.

With earnings season upon us expect the Q&A sessions to be filled with questions on both products. Investors will be looking for even the slimmest piece of information to gauge which drug will make it through the FDA first. Diabetic Investor won’t fall into that trap as it really doesn’t matter as one fact won’t change all the way through the process; Victoza is injected once-a-day while Byetta LAR is injected once-a-week. Everything else will make for some interesting copy but in the end it won’t change one fact; less frequent dosing wins over more frequent dosing. And yes it remains that simple.