The US Food and Drug Administration has approved Amylin Pharmaceuticals Inc.'s Bydureon as the first once-weekly treatment for type 2 diabetes after several years of delays due to concerns over the drug's safety.
The US Food and Drug Administration (FDA) has approved Amylin Pharmaceuticals Inc.’s Bydureon as the first once-weekly treatment for type 2 diabetes after several years of delays due to concerns over the drug’s safety.
Bydureon consists of exenatide extended-release for injectable suspension; a glucagon-like peptide-1 (GLP-1) receptor agonist, it is meant to be used in addition to diet and exercise to improve glycemic control in adults. Amylin’s Byetta, a twice-daily injectable drug containing exenatide, the same active ingredient as Bydureon, has been available in the US since June 2005.
According to a press release from the company, a 24-week clinical trial program entitled DURATION showed that type 2 diabetes patients treated with a once-weekly dose of Bydureon had improved glycemic control. Patients on Bydureon experienced a 1.6% reduction in hemoglobin A1C from baseline, compared with a 0.9% A1C reduction in patients on Byetta.
The FDA declined to approve Bydureon twice in 2010 due to concerns that it might contribute to heart problems. The agency has now approved the drug with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that its benefits outweigh its risks, including acute pancreatitis and the potential risk of medullary thyroid carcinoma.
Bydureon will be available in pharmacies nationwide in February.