Posted by Michael Wonder on 21 Nov 2016
Intarcia submits new drug application to FDA for U.S. marketing approval of ITCA 650 in type 2 diabetes
21 November 2016 - ITCA 650 is the first investigational drug to use Intarcia’s disruptive Medici Drug Delivery System to deliver chronic medicines just once or twice-yearly.
Intarcia Therapeutics announced it has submitted its new drug application to the U.S. FDA for ITCA 650 for the treatment of type 2 diabetes mellitus. The 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. 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 20 mcg/day three-month introductory dose and then followed by a 60 mcg/day six-month maintenance dose. Twelve-month mini-pumps at the 60 mcg/day maintenance dose are also in development.
