Diabetes drug Bydureon gains approval in the US

Tue, 31 Jan 2012
The drug, Bydureon, which is self-injected once per week by patients suffering from type 2 diabetes, has won approval by the Food and Drug Administration (FDA) in the United States. It is thought annual sales of the drug could eventually hit the USD1 billion mark if it’s seen as an alternative to taking multiple insulin injections every day.

Bydureon, developed by Amylin, Pharmaceuticals received the federal approval after many years of concern over whether it could contribute to heart rhythm abnormalities. The drug was twice turned down for approval in 2010. However, the FDA has also called on Amylin to conduct a clinical trial on whether Bydureon raises the risk of cardiovascular problems, such as heart attacks, as well as thyroid cancer and pancreatitis.

The drug will enter a market already dominated by Victoza, the daily injectable drug manufactured by Novo Nordisk , and is a longer-lasting version of Byetta, which is injected twice a day. All these drugs are GLP-1 receptor agonists, which act to copy the effect of the hormone glucagon-like peptide-1, and increase insulin production when blood sugar levels become too high.

However, although taking Bydureon means less injections, it may not become preferred choice ahead of Victoza, as some trials suggest that is somewhat less effective in the control of blood sugar, and is slightly more problematic to prepare and involves a bigger needle.

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