Bydureon | FDA holds off on approving extended-release Byetta
Today, the FDA announced that Eli Lilly’s extended-release diabetes drug Bydureon would not yet be approved.Bydureon is a long-release form of Byetta, and the FDA says it needs more data about the effect on heart rates. This FDA report sent Eli Lilly and Co. stocks down, while boosting competitors’ shares.
Bydureon is the new extended-release injection drug intended to help treat Type 2 diabetes. The drug is based on Byetta, an exenatide drug manufactured by Eli Lilly that is already on the market. The drug helps the body process glucose, which helps control blood sugar levels in individuals with non-insulin dependent diabetes. Byetta is only one of the drugs used to control Type 2 diabetes, though most drugs are only slightly more effective than proper diet and exercise. 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 potential dangers of Bydureon
Much like Byetta, Bydureon has several potential dangers. 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 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.
Bydureon’s effect on stock prices
Investors in Eli Lilly had originally expected the FDA to rule on Bydureon earlier this year. The two studies requested by the FDA will delay the decision until the middle of 2012. 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. Eli Lilly is planning for Bydureon to be its only major product launch in the next three years. With major drug patents expiring, the company has been facing serious declines in profit and stock prices.