BYDUREON(TM) Safety and Tolerability Pooled Summary Data

Data from nearly 1,100 patients in DURATION-1, -2 and -3 trials showed BYDUREON was well-tolerated….

Amylin, Eli Lilly and Company, and Alkermes, announced results of an analysis of pooled safety data from three completed randomized controlled trials that showed the investigational product BYDUREON (exenatide extended-release for injectable suspension), dosed once weekly, was generally well-tolerated with a low discontinuation rate due to serious adverse events similar to pooled comparators in patients with Type 2 diabetes.

Safety data from the DURATION-1, -2 and -3 trials involving patients on either BYDUREON or pooled data from comparator groups including Januvia® (sitagliptin), Actos® (pioglitazone HCI) or Lantus® (insulin glargine) were analyzed. The overall incidence rates of adverse events (AEs), serious AEs and discontinuations due to serious AEs were similar for BYDUREON versus pooled comparators. AEs occurred in 77 percent of patients receiving BYDUREON versus 71 percent for pooled comparators; serious AEs were 4 percent for BYDUREON versus 5 percent for pooled comparators; and discontinuations due to serious AEs were less than 1 percent for both groups. Discontinuation for nausea was similar in BYDUREON (0.7 percent) and pooled comparator (0.5 percent) cohorts. Hypoglycemic events were lower with BYDUREON, and composite exposure-adjusted incidence rates were similar for BYDUREON versus pooled comparators for pancreatitis, gall-bladder AEs, renal impairment/dehydration and thyroid-neoplasm AEs.

Orville G. Kolterman, M.D., senior vice president, chief medical officer, Amylin Pharmaceuticals, stated that, “The DURATION trials not only help us understand the potential of BYDUREON in improving blood glucose control as measured by A1c, but also its safety and tolerability,” said. “Overall, these data showed that BYDUREON was generally well-tolerated with a low discontinuation rate due to serious adverse events, adding to the potential of BYDUREON as a desirable treatment option for Type 2 diabetes in just one dose per week.”

BYDUREON (pronounced by-DUR-ee-on) is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for Type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA.

Amylin and Eli Lilly Press Release