Wider approval sought for diabetes drug Byetta

Drug giants Amylin Pharmaceuticals and Eli Lilly and Co. are looking for further approval from the Food and Drug Administration (FDA) in the US for the greater use of the diabetes drug Byetta, which is taken as an add-on therapy to basal insulin .
The FDA rejected a request for a long-acting version of Byetta last year, which has greatly delayed its approval and frustrated both companies, especially Amylin, which has still to make a profit since being launched publicly in 1992. Eli Lilly are also keen to develop more new treatments as they face generic competition to its top products.
Both firms have asked that Byetta be seen as an add-on therapy to basal insulin, or background insulin, regardless of the use of other diabetes drugs such as metformin and thiazolidinedione and in association with exercise and diet .
Orville G. Kolterma, chief medical officer for Amylin, commented “If approved for this expanded use, Byetta may provide a complementary addition to basal insulin to improve overall blood sugar control with no weight gain and no increased risk of hypoglycemia .” He also argued that the combination could be used as a mealtime treatment alternative that is taken twice a day and not need any dosage adjustments.

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