Diabetes drug candidate ITCA 650 filed for FDA approval

A New Drug Application filing with the US Food and Drug Administration for ITCA 650 as treatment of type 2 diabetes (T2D) has been submitted by the drug’s developer, Intarcia Therapeutics.

The NDA submission was made in close proximity to World Diabetes Day, and during National Diabetes month in America – two annual events that remind us that type 2 diabetes is one of the largest and fastest-growing public health crises in the world. #

If approved, ITCA 650 would become the first and only injection-free glucagon-like peptide-1 (GLP-1) receptor agonist therapy, according to privately-held Intarcia. ITCA 650 provides consistent and continuous subcutaneous delivery of exenatide via an osmotic mini-pump placed just under the skin in a simple in office procedure that only takes a healthcare provider a few minutes to perform. ITCA 650 mini-pumps were given with a 20mcg/day three-month introductory dose and then followed by a 60mcg/day six-month maintenance dose. 12-month mini-pumps at the 60mcg/day maintenance dose are also in development.