The first once-weekly diabetes drug has been approved by the Food and Drug Administration. An extended-release formulation of the type 2 diabetes medication exenatide, a glucagonlike peptide–1 (GLP-1) receptor, was approved last month, the manufacturer announced.
The formulation, called Bydureon, is administered once a week in a subcutaneous injection, and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The regular formulation of exenatide (Byetta), approved in 2005, is administered twice a day.
Approval was based on the results of the DURATION-5 study, which compared treatment with the two formulations in 252 patients with type 2 diabetes and inadequate glycemic control (mean baseline hemoglobin A1c was 8.4%) with diet and exercise alone or with oral therapy, including metformin, a sulfonylurea, a thiazolidinedione, or a combination of two of these treatments.
The mean reduction in HbA1c was 1.6 percentage points in those treated with 2 mg of extended-release exenatide once weekly, compared with a reduction of 0.9 percentage points in those treated with the regular form of exenatide, a statistically significant difference, according to the prescribing information.
Bydureon has been approved with a Risk Evaluation and Mitigation Strategy to ensure that the benefits of the drug outweigh the risks of acute pancreatitis and the “potential” risk of medullary thyroid cancer with treatment. There have been postmarketing reports of pancreatitis associated with exenatide, including nonfatal hemorrhagic or necrotizing pancreatitis.
Bydureon is contraindicated in people with a personal or family history of medullary thyroid cancer or those with multiple endocrine neoplasia syndrome type 2.