Bydureon: Diabetes Drug Injected Weekly Wins FDA Approval

Amylin Pharmaceuticals once weekly injectable drug, Bydureon, a synthetic GLP-1 receptor agonist was approved by the FDA in January 2012 for the treatment of T2D. Other drugs in this class include Byetta and Victoza, both of which require more frequent dosing (1-3 times a day). In addition to the convenience and considerably reduced burden of a weekly dosing schedule, Bydureon showed increased efficacy without affecting the safety profile in clinical studies in T2D patients. It is predicted that drugs like these are likely to become a main line of treatment for T2D. This class of therapeutics has added benefits of weight loss and lipid reduction. Given that one of the mechanisms of action of this class of drugs is suppression of glucagon, it is anticipated that Bydureon may benefit individuals with T1D as well.

Reference:

FDA Approves BYDUREON – The First and Only Once-Weekly Treatment for Type 2 Diabetes: Provides Glycemic Control in a Once-Weekly Dose. [http://www.multivu.com/mnr/53897-amylin-alkermes-plc-bydureon-fda-approved-treatment-type-2-diabetes

Ramifications for Individuals with Type 1 Diabetes:

GLP-1 receptor agonists may have the potential to benefit individuals with T1D. These drugs work by more than one mechanism/pathway which could benefit individuals that are at-risk for developing T1D (prevent/delay onset), newly diagnosed T1D (delay/retard beta cell loss), and certainly people with established T1D (with or without residual insulin secretion). A vast body of preclinical literature in T1D models and quite a number of small clinical studies collectively provide sufficient evidence to warrant examining mechanisms by which such drugs may benefit individuals with T1D, and determine which patient population/s are likely to benefit from this therapeutic class.

JDRF Involvement:

Amylin Pharmaceuticals supported the development of this new product. JDRF currently has two ongoing partnerships with Amylin focused on other therapies (pramlintide and leptin) and are actively exploring potential studies of Bydureon in T1D.