Intarcia Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for active review its New Drug Application (NDA) for ITCA 650, an investigational therapy for the treatment of type 2 diabetes (T2D). Intarcia looks forward to working closely with the FDA through the review process.
ITCA 650 provides continuous delivery of exenatide via an osmotic mini-pump placed just beneath a patient’s skin in the abdominal wall. It is designed to do this by leveraging Intarcia’s innovative and proprietary technology, the Medici Drug Delivery System.
In studies, 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, which translates to twice-yearly dosing after initiation.