Amylin, Lilly seek FDA approval for once-weekly diabetes injector
Amylin Pharmaceuticals, Eli Lilly and Alkermes have submitted to the FDA a new drug application (NDA) to the FDA for exenatide once weekly, an investigational sustained release medication for type 2 diabetes that is injected subcutaneously and administered once a week.
Exenatide is the active ingredient in Byetta (exenatide) injection, which is currently available in the U.S. and in many countries worldwide for people with type 2 diabetes who are unable to achieve good glycemic control with common oral therapies, according to the San Diego-based Amylin, the Indianapolis-based Lilly and the Cambridge, Mass.-based Alkermes.
Clinical components of the NDA include the DURATION-1 study and the meta-analysis of primary cardiovascular events across the Byetta clinical database. DURATION-1 was designed to test the superiority of exenatide once weekly, as compared to Byetta, which is administered twice daily. In the study, exenatide once-weekly treatment resulted in statistically significant reductions in A1C of 1.9 percentage points from baseline, compared to a reduction of 1.5 percentage points for Byetta and 77 percent of patients treated with exenatide once weekly achieved an A1C of 7 percent or less compared to 61 percent of patients treated with Byetta. Exenatide once weekly and Byetta were both associated with an average weight loss of eight pounds from baseline.
The most commonly reported adverse event was nausea, and occurred less frequently in the exenatide once weekly patients. In addition, the analysis across controlled clinical studies of three months or greater from the Byetta database showed no increased risk of cardiovascular events associated with exenatide use.
Exenatide is the active ingredient in Byetta (exenatide) injection, which is currently available in the U.S. and in many countries worldwide for people with type 2 diabetes who are unable to achieve good glycemic control with common oral therapies, according to the San Diego-based Amylin, the Indianapolis-based Lilly and the Cambridge, Mass.-based Alkermes.
Clinical components of the NDA include the DURATION-1 study and the meta-analysis of primary cardiovascular events across the Byetta clinical database. DURATION-1 was designed to test the superiority of exenatide once weekly, as compared to Byetta, which is administered twice daily. In the study, exenatide once-weekly treatment resulted in statistically significant reductions in A1C of 1.9 percentage points from baseline, compared to a reduction of 1.5 percentage points for Byetta and 77 percent of patients treated with exenatide once weekly achieved an A1C of 7 percent or less compared to 61 percent of patients treated with Byetta. Exenatide once weekly and Byetta were both associated with an average weight loss of eight pounds from baseline.
The most commonly reported adverse event was nausea, and occurred less frequently in the exenatide once weekly patients. In addition, the analysis across controlled clinical studies of three months or greater from the Byetta database showed no increased risk of cardiovascular events associated with exenatide use.