FDA Gives Bydureon Clean Approval

FDA Gives Bydureon Clean Approval

Late this afternoon Amylin (NASDAQ:AMLN) and Alkermes (NASDAQ:ALKS) finally received word that the FDA approved their once-weekly GLP-1 Bydureon™. Even better the approval came with NO BLACK BOX warnings which will give Amylin another advantage when competing against Novo Nordisk (NYSE:NVO) and their once-daily GLP-1 Victoza®. (Amylin will also have the additional benefit of not having their spokesperson being a fat, hypocrite who is getting continually reamed in the media and placing the drug she is endorsing in an unfavorable light.)

Now as everyone knows Diabetic Investor has been predicted this approval for some time and the only real question in our mind was whether the FDA would look at the scientific evidence or would they hit Bydureon with unreasonable label restrictions, thankfully the FDA followed their mission and the science. The company did note in their press release; “BYDUREON has been approved with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of BYDUREON outweigh the risk of acute pancreatitis and the potential risk of medullary thyroid carcinoma.”

While this approval is a great event for Amylin, Alkermes and patients it is only the beginning of what surly will be a tough fight with Novo who began selling against the drug well before its official approval. Diabetic Investor also believes investors should not place too much emphasis on the initial sales numbers for Bydureon as we anticipate while it has the potential to become a game changer, physicians will likely follow their typical pattern of testing the drug on a few patients before prescribing it to a greater share of their diabetes patient population. Additionally the real game changing event will come when Bydureon comes in an easy to use patient friendly pen.

As we noted previously the initial version of Bydureon will require greater patient interaction and slightly more patient education. Even so we do not anticipate these additional steps will prevent adoption especially since the drug only needs to be administered once a week.

Based on comments made during this afternoon’s conference call we further anticipate Amylin will price Bydureon aggressively putting even more pressure on Novo. As we reported late last year based on pricing in Europe Bydureon was actually priced LOWER than Victoza. Amylin is well aware how important this launch is to their future and will leave no stone unturned to insure that Bydureon gets off to a good start. They are also well aware of what happened the last time they launched a drug but thankfully this time around they won’t have to deal with an inept partner who did more harm than good.

Even with the delay this truly is an exciting day for the entire diabetes community. The harsh reality when it comes to managing diabetes is therapy compliance is by far one of the biggest obstacles to better patient outcomes. This is true not just for injectable therapies like insulin but also for oral medications too. In the real world the majority of diabetes patients taking oral medications to control their diabetes are also taking additional pills for other issues. It is not unusual for these patients to be taking 6 to 10 pills EACH day. Think for a moment how much easier their lives would be by taking a drug just once a week, a drug that offers solid glucose control, does not require glucose monitoring and comes with added benefit of weight loss.

The simple fact is when it comes to treating diabetes less is more, something that was proven when Lantus was launched. Lantus should serve as a model for Bydureon as it disproved many myths – first everyone said type 2 patients would not inject – next we heard that type 2 patients would not understand how to properly dose their insulin and finally we heard that type 2 patients would suffer from hypoglycemia. Well as it turns out type 2 patients don’t mind injecting, with Bydureon they won’t have to worry about dosing as it comes with a fixed dose and finally there is little risk of hypoglycemia with Bydureon.

It is not an understatement to say that Bydureon has the potential to become the next mega-blockbuster in the diabetes space and more importantly change the paradigm for treating type 2 diabetes. A hearty congratulation to all the folks at Amylin who’ve weathered many tough times and a partner who was too dumb to realize what they had and will live to rue the day they didn’t buy this company when they had the chance.

The diabetes drug space just became much more interesting.