FDA resubmits once-weekly diabetes therapy as class 2

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The FDA has classified Bydureon (Amylin Pharmaceuticals, Eli Lilly and Alkermes), a weekly exenatide injection used to treat type 2 diabetes, as a class 2 resubmission and assigned the drug a Prescription Drug User Fee Act (PDUFA) action date of Oct. 22.

Bydureon is an extended-release medication that delivers Byetta, an FDA approved glucagon-like peptide-1 (GLP-1) receptor agonist class of medications. According to the companies, Byetta provides glucose control in patients with type 2 diabetes mellitus when combined with an exercise regiment.

However, since its approval in 2005, warnings have linked Byetta to the formation of acute pancreatitis. Patients with severe kidney problems or who have had prior kidney transplant should refrain from taking the drug.

Additionally, Byetta can be administered alone or in conjunction with metformin or a thiazolidinedione for potential weight loss.