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Byetta data raises significant concerns regarding the drug’s effect on heart rhythm

In an effort to receive approval from the FDA for its new diabetes drug Bydureon, Amylin Pharmaceuticals deliberately concealed relevant information pertaining to heart – safety issues surrounding the drug. Even after such concerns were made public, Amylin went even further in attempting to hinder FDA access to data showing Bydureon’s pitfalls. The series of events can be traced back to a Canadian tQT study of Byetta, Bydureon’s predecessor, which raised significant concerns regarding the drug’s effect on heart rhythm. FDA approval of Bydureon was to be partially predicated on efficacy and safety data from Byetta clinical trials, and seeing as Amylin failed to report such findings to the FDA during its regulatory review of the drug, it can be concluded that the company’s intentions were calculated and misleading. When the FDA was alerted to Bydureon’s potential heart hazards, Amylin was told that an entirely new tQT study of the drug would have to be conducted. Only after the study demonstrated a clean heart – safety profile for Bydureon would Amylin be able to resubmit the drug again for review. Moreover, Amylin withheld the tQT study of Byetta from the FDA and failed to include the troublesome heart – safety data in the initial Bydureon approval filing in order to ensure that such delaying processes could be avoided.

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