Byetta Denied Approval from FDA, Needs Clarification


The executives at Amylin, Lilly and Alkermes appear positive amidst the denial of their new type 2 diabetes drug, Byetta. The Food and Drug Administration (FDA) didn't request further trials, but the biotechnology companies still see the denial as another step to releasing Byetta in the future. Denial came in the form of a complete response letter.

"This is a significant step forward in our ability to bring this important therapy to patients," stated Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "We have a clear path forward and are working diligently to submit our response to the FDA in the next few weeks."

Byetta's disapproval related to product labeling and Risk Evaluation and Mitigation Strategy (REMS). New treatment drugs are subjected to REMS because of potential risks involved from side effects and abuse liability, as reported in the Annals of the New York Academy of Sciences.


The type 2 diabetes treatment drug, Byetta, is an injectable prescription medicine that helps to control blood sugar levels in adults with type 2 diabetes millitus, and is recommended to be taken without insulin.

The American Diabetes Association describes the numerous side effects of diabetes treatment drugs, making any potential risks a serious factor for innovative treatments waiting for approval. Byetta's most serious risk appears to be low blood sugar, which is also why it is not recommended for patients with type 1 diabetes.

A serious risk of Byetta is acute pancreatitis, a potentially fatal hemorrhagic or necrotizing pancreatitis. More common side effects include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach, which apparently dissipate after the initial weeks of taking the drug.

Amylin is planning on hosting a conference call to further discuss the FDA's complete letter today. A webcast will be conducted through Amylin's corporate website, with a recording available following the conference call.