New Diabetes Drug Denied FDA Approval.... For Now.

It could be close to two years before Bydureon, a new diabetes drug whose approval was just rejected by the U.S. Food and Drug Administration (FDA), gets another shot at coming to market.

The drug, being developed by Amylin Pharmaceuticals and Eli Lilly, will need to undergo further testing, including a trial that looks for possible cardiac risks, before the FDA reconsiders its approval.

The drug, whose active ingredient — exenatide — comes from the saliva of the Gila monster, is a longer-lasting version of a similar drug already on the market, Byetta. Byetta is used to improve blood sugar control in people with type 2 diabetes, often in combination with other drugs.

While Byetta must be injected twice a day, Bydureon could be injected once a week.
However, if Byetta is any indication of the risks that lie ahead with Bydureon, the FDA made a wise choice in delaying its approval. Just two years ago, the FDA strengthened warnings on Byetta due to potentially life-threatening pancreas problems after two deaths and hospitalizations were reported.
Even Byetta’s Web site states that serious side effects “including inflammation of the pancreas (pancreatitis) which may be severe and lead to death” can occur in people who take the drug. Other known side effects include low blood sugar, kidney problems (including kidney failure that may require dialysis or kidney transplant), severe allergic reactions, vomiting, jittery feelings, acid stomach, headache and more.

There’s no telling which of these side effects, or others, may be associated with Bydureon as well if it ends up getting approved in 2012.

As always, it’s important to be well aware of the serious risks that come with taking medications for diabetes, and decide, along with your health care practitioner, if diet and lifestyle strategies could lead to similar improvements in your blood sugar control — without all the risks.
You’ll find that, often, a treatment plan individually tailored to your own underlying causative factors will resolve type 2 diabetes in a much safer, deeper and more effective way than drugs ever could.

NYTimes.com October 19, 2010
Yahoo News October 19, 2010