Diabetes drug Byetta expected to receive new European approval

Mon, 20 Feb 2012
The pharma companies behind the twice-daily injection drug Byetta, which is taken by patients that have developed type 2 diabetes, have stated that a panel providing guidance to the European Medicines Agency (EMA) has signalled that it should receive approval. The drug was first approved in Europe in 2006, so that it could be sold to patients who were not able to effectively control their blood sugar on the usual diabetes treatments, such as metformin.

The two American firms, Amylin Pharmaceuticals and Eli Lilly, said last week that the panel has recommended approval for Byetta, also known as Exenatide, in terms of its use in combination with basal insulin with or without other regular diabetes treatments for people who have been unable to control their levels of blood sugar through other means. If the agency does grant approval – and notice of their decision is expected during the next couple of months – then Byetta would be marketed at this group of diabetes patients.

Although EMA is not required to agree with the findings of the panel, it often does so. This follows both companies announcing last November that they were stopping their collaboration on Byetta, as well as its successor, the weekly therapy Bydureon, and that Amylin is now taking over the marketing of Byetta outside the United States.

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