Once-weekly diabetes drugs poised for approval – Nature Medicine News Article
The announcement last month that drugmakers Amylin Pharmaceuticals and Eli Lilly were parting ways is only the latest twist in their more than two-year quest for regulatory approval of their once-weekly injectable diabetes medication, Bydureon. The companies first filed for approval with the US Food and Drug Administration (FDA) in May 2009, and in the intervening period they have had to deal with two complete response letters for manufacturing issues and potential heart problems. But with new trial data in the bank and Bydureon’s European approval in June, things are looking up, and a decision is expected from the FDA by 28 January.
“I think that the FDA will very likely approve Bydureon,” says senior biotechnology analyst Thomas Wei of the investment firm Jefferies in New York. “And a big part of the reason I think that this will be successful is that the efficacy looks very good.”
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