Weekly Byetta clears heart rate hurdle

July 12th, 2011 by Ryan Luce No Comments

written by Michael O'Leary

Good news for people who have had good results controlling the HbA1c with BYETTA®. The Associated Press, Reuters report that new study results of the once-a-week formulation of the drug show that the drug does not affect heart rate.

Last October, the FDA declined approval of the once-a-week BYDUREON™ for type 2 diabetes and requested that the drug’s maker, Amylin Pharmaceuticals, provide more information about the drug’s effect on patients’ heart rates. (Link to published site)

BYDUREON  (by-DUR-ee-on) combines the active ingredient in BYETTA, called exenatide, with a technology developed by Alkermes, Inc to provide a sustained release delivery of the drug, which allows once-a-week injections. The drug can be taken alone or with other diabetes medications. Exenatide was a first-in-class GLP-1 receptor agonist. GLP-1 stimulates the release of insulin when glucose levels become too high.

The study conducted by Amylin looked at whether doses of BYDUREON at or above prescription levels affected the elapsed time between two key phases of the heartbeat.  Researchers gave the drug or a placebo to 75 healthy volunteers. The results showed that BYDUREON did not interfere with the electrical activity of the heart even at high doses, a key safety measure in drug trials.

According to Amylin’s papers filed with the SEC, a 2008 study compared patients taking twice-daily BYETTA to those taking the once-weekly formula for 30 weeks. After 30 weeks the twice-daily patients were allowed to switch to the weekly BYDUREON formula for another 22 weeks. Both groups achieved similar improvements in A1C.

The results showed that 72 percent of patients treated with exenatide once a week achieved an A1C of 7% or less and 54 percent achieved an A1C of 6.5 percent or less. In patients who switched from BYETTA to exenatide once weekly, 75 percent of patients achieved an A1C of 7 percent or less and 53 percent achieved an A1C of 6.5 percent or less.

Perhaps, just as significantly as the A1C control, exenatide once weekly was associated with an average weight loss of 9.5 pounds over 52 weeks.

Amylin, Alkermes, and Eli Lily & Co. are asking for FDA approval to market the drug in the U.S. The drug has already been approved for sale in Europe.