FDA approval still not offered for Bydureon

Today, the FDA announced that Eli Lilly’s extended-release diabetes drug Bydureon would not yet be approved. Byetta is a drug that has been on the industry for a while. Bydureon is simply an extended-release form of the drug, but the FDA wants more details on side effects. Eli Lilly, maker of both drugs, saw a huge drop in stock price when this announcement had been made.

What Bydureon will work for

It appears that Bydureon is injected. It is intended to help Diabetes type 2 with things. Eli Lilly manufactures Byetta, which is an exenatide drug, which is what the drug utilizes one of the most. Processing glucose is what the drug helps to do the very best. This works in non-insulin dependent diabetes which can control blood sugar better. Proper diet and exercise can do almost precisely what most Diabetes type 2 drugs do like Byetta does as well. Controlling food intake and becoming physically healthy with exercise will do the most for those with Diabetes type 2 although drugs can help.

What possible troubles could come from Bydureon

Byetta and Bydureon are alike. Potential risks are associated with both. The FDA has requested at least two more studies on the effects Bydureon may have on user’s heart rates. Byetta has a lot of known things associated with it. These include changes in behavior and mood, headaches, dizziness and clumsy movements. Bydureon, as an extended-release dose of the very same drug, could have stronger potential side effects.

How stock has changed due to Bydureon

The Bydureon ruling from the Food and Drug Administration was expected earlier this year. That is what Eli Lilly investors were expecting. The FDA requested two more studies be done. This means that before the middle of 2012, a decision won’t be made. More than $1 billion in sales of Bydureon every year is becoming pushed by Eli Lilly. The delay is bad for the business. It means rivals can catch up fast. Eli Lilly is planning for Bydureon to be its only major product launch in the next three years. Profits and stock values are going down for the company since major drug patents are expiring.

Info from

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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