Eli Lilly Submits GLP-1 dulaglutide to FDA and Unveils Injection Device

Eli Lilly announced in October the submission of dulaglutide, its once-weekly GLP-1 receptor agonist for type 2 diabetes, in the US and Europe. This means a regulatory decision is expected in late 2014. There are currently three GLP-1 agonists available in the US: Novo Nordisk’s once daily Victoza (liraglutide) and Amylin/BMS/AZ’s twice-daily Byetta (exenatide) and once-weekly Bydureon (exenatide once-weekly). In studies presented at the ADA 2013 annual meeting, 60-80% of patients on dulaglutide were able to reach an A1c goal of 7.0% or below. More trials on dulaglutide are ongoing and results are expected in 2014.

Eli Lilly also revealed a dulaglutide injection device designed to lessen injection anxiety. Importantly, dulaglutide will be in a ready-to-use preparation with an automatic injection. With a push of a button, the device will extend the needle, deliver the drug, and retract so that users never have to see or handle the needle itself. This is far less complicated than the current once-weekly Bydureon kit, which requires drug mixing and needle prep prior to use. –NL/MV