Photo of the FDA logo.
The FDA won't approve a new diabetes med until more data is collected. CC by FitzColinGerald/Wikimedia Commons

The FDA has said that it will not yet be approving Bydureon. Bydureon is an extended-release drug that is intended as a once-a-week dose of Byetta. The shares in Eli Lilly dropped when this announcement was released. Shares of competitors companies went higher.

What Bydureon is good for

Bydureon is injected. It is supposed to help with Type 2 diabetes. Eli Lilly manufactures Byetta, which is an exenatide drug, which is what the drug uses the most. Individuals with non-insulin dependent diabetes can more easily process glucose, helping blood sugar, levels with this drug. Byetta is just like all the other drugs Type 2 diabetes is controlled with. Of course, proper diet and exercise are almost as effective as the drugs. While Type 2 diabetes drugs help, the best way to combat the disease is for individuals to manage it through controlling food intake and getting the right amount of physical activity.

The dangers associated with Bydureon

Much like Byetta, Bydureon has several potential dangers. The FDA won’t approve the drug without more studies. The effect of Bydureon on heart rates is what the studies will be about. Byetta has been known to cause clumsy movements, dizziness, headaches and changes in behavior and mood. Bydureon, as an extended-release dose of the same drug, could have stronger potential side effects.

Is Bydureon affecting stock?

The Bydureon ruling from the FDA was expected earlier this year. That is what Eli Lilly investors were expecting. The decision can’t be made until the middle of 2012 because of the two studies the FDA wants done. Eli Lilly has been pushing very aggressive sales goals for Bydureon – more than $1 billion per year. With this delay, competitors will have a chance to catch up. Bydureon is the only thing Eli Lilly is planning to release for a few years. Profits and stock prices have been going down for the company since major drug patents have been expiring.

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