Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Amylin Pharmaceuticals and Eli Lilly and Company have received the European Commission approval for BYETTA (exenatide twice-daily) as an adjunctive therapy to basal insulin, with or without metformin and/or Actos for the treatment of type 2 diabetes.
Subscribe to our email newsletter
The approval was based on a double-blind trial, in which BYETTA 10 micrograms or placebo was added to existing insulin glargine therapy, which was titrated to achieve target fasting glucose levels.
The primary endpoint was reduction in A1C, a measure of average blood sugar over three months.
The secondary endpoints were change in body weight along with other parameters of glucose control, cardiovascular health, hypoglycemia and patient-reported outcomes.
After 30 weeks of treatment, BYETTA demonstrated a statistically significant reduction in A1C compared to placebo, lowering A1C by 1.7% points from a baseline of 8.3%.
Amylin research and development senior vice president Christian Weyer said the marketing authorization for the use of BYETTA with basal insulin provides a new option for the many patients with type 2 diabetes who are not achieving treatment goals.