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After two earlier rejections in 2010, Amylin Pharmaceutical’s diabetes drug Bydureon finally won the Food and Drug Administration FDA)’s approval on Friday.
According to Amylin, Bydureon is the first-of-its-kind drug which offers glycemic control for ‘Type 2’ diabetes patients; and it essentially is a once-a-week version of the company's 7-year-old diabetes treatment Byetta which is a twice-a-day injection.
Following the approval by the FDA, the Bydureon drug – which is a glucagon-like peptide-1 (GLP-1) receptor agonist – can be used alongside diet and exercise, for improving blood sugar control in adults suffering from Type 2 diabetes.
While Bydureon was previously rejected two times by the FDA which asked Amylin to carry out a new trial of the effect of the drug on heart rhythm, it was finally approved after the company submitted safety and efficacy data from the DURATION clinical trial of the drug, along with the clinical experience with Byetta.
The pharmaceutical company has now said that Bydureon will be available in medical stores all across the US from next month.
Noting that Bydureon will give doctors as well as Type 2 diabetics the option of a treatment which can offer continuous control of blood sugar with a once-weekly dose, Dr John Buse - a professor of medicine, and the director of the Diabetes Care Center - said: “New treatment options are essential for the millions of adults with type 2 diabetes who continue to struggle to achieve optimal blood sugar control.”