Intarcia have submitted its New Drug Application (NDA) to the Food and Drug Administration (FDA) for ITCA 650, a novel, subcutaneous glucagon-like peptide-1 (GLP-1) receptor agonist therapy for the treatment of type 2 diabetes (T2D). If approved ITCA 650 would become the first injection-free GLP-1 receptor agonist therapy.
ITCA 650 provides consistent and continuous subcutaneous delivery of exenatide via an osmotic mini-pump (the size of a matchstick) placed just under the skin in an in-office procedure done by a trained healthcare professional. It is designed to hold enough medication to treat a patient for up to a full year, employing Intarcia’s subcutaneous delivery system, the Medici Drug Delivery System.
The NDA is based on results from four Phase 3 clinical studies which enrolled more than 5,000 subjects (Freedom-1, Freedom-1 HBL, Freedom-2, and Freedom-CVO). Each trial was successfully completed and met its primary endpoints, demonstrating superior efficacy vs. placebo and sitagliptin. In clinical trials, ITCA 650 mini-pumps were given with a 20mcg/day 3-month introductory dose and then followed by a 60mcg/day 6-month maintenance dose. Twelve-month mini-pumps at the 60mcg/day maintenance dose are also in development.
“Instead of working on yet another incremental pill or injection, our mission is to open up a totally new and disruptive pathway of delivering effective medicines just once or twice-yearly with built in compliance and adherence,” said Kurt Graves, Chairman, President and CEO of Intarcia.
For more information visit Intarcia.com.