Amylin Pharmaceuticals and Alkermes have announced that the US Food and Drug Administration (FDA) has approved Bydureon (exenatide extended-release for injectable suspension) for the treatment of type 2 diabetes.
Bydureon, previously known as exenatide, is a glucagon-like peptide-1 (GLP-1) receptor agonist, used as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes patients.
The move follows the safety and efficacy data from the Duration clinical trial programme, which demonstrated improvements in glycemic control with just one dose per week.
Bydureon leverages Alkermes’ proprietary technology for long-acting medications to help make its own insulin when needed, enabling continuous glycemic control with just one dose per week, and to provide a controlled release of exenatide.
The Duration-5 head-to-head clinical study reported that patients taking once-weekly Bydureon experienced a considerable reduction in A1C of 1.6% points from baseline, compared to a reduction of 0.9% points for patients taking Byetta.
"As the first and only once-weekly diabetes treatment, Bydureon represents an important milestone in Amylin’s promise to bring to market innovative therapies to help improve the lives of people with type 2 diabetes," said Amylin Pharmaceuticals CEO and president Daniel Bradbury.
"Bydureon builds upon the proven benefits of Byetta, offering significant improvements in glycemic control in a single weekly dose."
Based on earlier post-marketing data, exenatide has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotising pancreatitis.
The company said Bydureon should not be used in people who have or had severe kidney problems and may cause or worsen problems with kidney function, including kidney failure.
The drug-related side effects included nausea, diarrhoea, headache, vomiting, constipation, itching at injection site, a small bump (nodule) at the injection site, and indigestion.
Amylin Pharmaceuticals is a biopharmaceutical company focused in discovery, development and commercialisation of innovative medicines against diabetes, obesity and related metabolic disorders.
Alkermes’ diversified portfolio of drug products addresses central nervous system (CNS) disorders such as addiction, schizophrenia and depression.