Byetta Heart Risk Information Concealed from FDA: Memo

Recently revealed government records suggest that Amylin Pharmaceuticals may have attempted to hide information about the potential risk of heart problems from Byetta, which was a factor in the FDA’s delayed approval for a new long-lasting version of the diabetes drug that is marketed under the brand name Bydureon.

Byetta (exenatide) was originally introduced in April 2005, as a twice a day subcutaneous injection administered to help reduce blood sugar levels in type 2 diabetics. Bydureon is a longer-acting version of the medication that was approved in January 2012, allowing users to take one dose a week to regulate their diabetes.

According to a Bydureon approval memo, which was recently posted by the FDA, the approval process for Bydureon was complicated by Amylin’s actions in concealing information about the potential Byetta heart risks, which the FDA deemed important to the evaluation of the safety and effectiveness of the new diabetes drug.

“FDA was not informed by Amylin that Health Canada considered several findings from tQT study concerning enough such that approval was delayed in Canada because agreement on product labeling could not be reached,” the agency wrote in a recently released memo. “On April 12, 2008, Health Canada notified FDA of this study and its implications to both Byetta and Bydureon risk assessments.”

The study looked at the side effect of Byetta on heart rhythms. Its findings suggested that patients with kidney problems may have their heart rhythms adversely affected by the medication, which raised concerns during the Bydureon approval process.

The FDA rejected Bydureon twice before approving the medication with requirements that Amylin include a Risk Evaluation and Mitigation Strategy (REMS), which is a special program designed to ensure the drug is not used by patients for whom the risks outweigh the benefits.

In addition to concealing information from the FDA, Amylin also reportedly lied to investors about the reason for the FDA’s earlier rejection of the drug, failing to disclose that concerns over the Byetta heart safety study played a role in the review.