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FDA Approves Bydureon, a Novel, Once-Weekly Diabetes Therapy for Type 2 Patients

On January 27, the Food and Drug Administration (FDA) granted approval to Bydureon, a new drug for type 2 diabetes that is injected once a week. Approved last year in Europe, and now approved in 31 countries and available in 10, the drug should be available in US pharmacies by mid-February of this year. Bydureon’s approval comes after a series of regulatory setbacks, as the approval was initially expected in 2010; but the FDA denied the drug on two occasions because of concerns about its label and about its effect on heart rhythms. These concerns were put to rest by a clinical trial of very high doses of exenatide (the active ingredient in Bydureon), in which the drug was shown not to significantly affect heart rhythms. That European regulatory authorities had also approved the drug also made it more likely it would be approved here in the US, and indeed, the third time was the charm. We had the opportunity to test the delivery device in Europe, where Bydureon has been approved since last June, and we describe our experience in the NewNowNext of diaTribe #36. For more information on the development of Bydureon, see the Learning Curve in diaTribe #26.

Like other approved GLP-1 agonists, Bydureon provides glucose control (A1c reduction of 1.3%-1.9%), with the potential for weight loss (typically about six pounds), and no increased risk of hypoglycemia or need for dose adjustment. However, Bydureon has the advantage of requiring just one injection per week.

Bydureon belongs to a relatively new class of diabetes drugs called GLP-1 receptor agonists, first approved in 2005, which stimulate the body to produce insulin only when blood glucose levels become too high. Like other approved GLP-1 agonists, Bydureon provides glucose control (A1c reduction of 1.3%-1.9%), with the potential for weight loss (typically about six pounds), and no increased risk of hypoglycemia or need for dose adjustment. In particular, the combination of no hypoglycemia and weight loss in most patients (rather than weight gain, as is commonly seen with insulin and TZDs), have made this class very appealing to doctors and healthcare educators (see the Learning Curve in diaTribe #24 for more details).

Bydureon is the third GLP-1 receptor agonist to reach the US market, after Byetta in 2005 and Victoza in 2010. While Bydureon and Byetta share the same active ingredient (exenatide), Byetta is typically injected twice a day whereas Bydureon uses “microspheres” that degrade slowly in the body allowing for once-weekly dosing (this short film clip by the manufacturer explains how this works here). In addition to added convenience, Bydureon has shown greater reductions in A1c than Byetta and significantly lower rates of nausea and vomiting. One disadvantage of Bydureon, compared to both Victoza and Byetta, is that it uses a larger needle (23 gauge and just under 8 mm long for Bydureon vs. 32 gauge and 4 mm long for Byetta and Victoza) and requires reconstitution (mixing the drug with a liquid) before its use. New versions of Bydureon that do not require reconstitution are currently in development, and we expect a “Bydureon pen” by early 2013.

In the meantime, if you have type 2 diabetes and are looking to improve your glucose management, you can ask your doctor about Bydureon. For those paying out of pocket, Bydureon will be $31 per month more expensive than Byetta ($323 vs. $292), but will be slightly less expensive than the highest dose of Victoza. The higher price relative to Byetta makes sense to us since it’s more expensive to make and took substantial resources to develop and get approved; we expect insurance coverage in the US to be good, for those lucky enough to have insurance. As we understand it, the manufacturer of Bydureon plans to offer a co-pay savings program (up to $50 per month for two years) for certain eligible patients.

We applaud the approval of Bydureon in the US and believe that many people with diabetes will appreciate the convenience of once-weekly dosing. Some patients may still prefer the smaller needle size and once-daily dosing of Victoza, at least until a pen is available – only time will tell. Because it is more rapid-acting, Byetta (taken twice daily – or even three times daily by some) may continue to be preferred by some patients, in combination with basal insulin to control glycemic spikes after a meal. We welcome the fact that patients now have multiple GLP-1 options, and we look forward to diaTribe’s Test Drive on Bydureon, coming soon! –MY

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