January 30, 2012

FDA approves once-weekly Bydureon

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Amylin Pharmaceuticals rejoices as the third attempt to gain FDA approval for Bydureon, the once weekly injectible diabetes drug, was finally approved. Third time’s the charm!

Bydureon is a glucagon-like peptide-1 (CLP-1). a class of drugs that help the body produce more insulin, which helps regulate blood sugar. Amylin has had Byetta on the market for several years but dosing requires injections twice a day.

Amylin has viable competition in Victoza. Is that Paula Deen promoting the prodct? Amylin feels that Bydureon has the potential to be a blockbuster drug because it may enhance patient compliance. As a weekly injection that offers blood glucose control, possible weight loss, and improved quality of life with diabetes- this is a win, win, win.

Bydureon was submitted to the FDA two times before it was approved. The drug was found to cause abnormal heart rhythms. Somehow the FDA did not see that as a prohibiting issue this time around. The once-weekly injection will include a label warning that the drug shouldn’t be used by people with a family history of medullary thyroid carcinoma. Plain as day – the warning is in there, albeit medical jargon.

Despite the writing on the box it is quite possible that the enhancements offered to people with type 2 diabetes may provide a week long hiatus from the burden of diabetes distress. Bring it, Bydureon!

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