More info required prior to when Bydureon gets FDA approval

Bydreon, a drug that has been submitted to the Food and Drug Administration for approval, isn’t getting the go-ahead just yet. The FDA is worried about the heart rate effect of Bydureon. Byetta is a drug already authorized that is the basis of Bydureon. This FDA record sent Eli Lilly and Co. stocks down, when boosting competitors’ shares.

The numerous uses of Bydureon

Bydureon is the new extended-release injection drug meant to help treat Type 2 diabetes. Eli Lilly manufactures Byetta, which is an exenatide drug, which is what the drug uses one of the most. Individuals with non-insulin dependent diabetes can more very easily process glucose helping blood sugar levels with this drug. Byetta is just like all the other drugs Diabetes type 2 is controlled with. Of course, correct diet and exercise would be practically as effective as the drugs. While Type 2 diabetes drugs help, the best way to combat the disease is for individuals to manage it via controlling food intake and getting the right amount of physical activity.

The risks associated with Bydureon

You will find hazards that can happen with Bydureon, just like Byetta. The FDA has requested at least two more studies on the effects Bydureon may have on user’s heart rates. Byetta has been known to trigger clumsy movements, dizziness, headaches, and changes in behavior and mood. Bydureon, as an extended-release dose of the very same drug, might have stronger potential side effects.

Share prices becoming impacted by Bydureon

The Bydureon ruling from the FDA had been expected earlier this year. That is what Eli Lilly investors were expecting. The Food and Drug Administration requested two more studies be done. This means that until the middle of 2012, a decision will not be made. Eli Lilly really wants more sales of Bydureon. More than $1 billion every year is becoming pushed. Rivals could be able to catch up with the long delay. Bydureon is the only thing Eli Lilly is preparing to take place in a few years. With major drug patents are expiring, the business has been facing significant declines in profit and share prices.

Articles cited

Drugs.com

drugs.com/byetta.html

IBJ.com

ibj.com/fda-demands-more-tests-on-new-lilly-diabetes-drug/PARAMS/article/22930

Reuters

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