Intarcia Therapeutics has announced that the US 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.
Intarcia Therapeutics, is a biopharmaceutical company developing therapies to enhance treatment and prevention outcomes by optimizing and improving the efficacy, continuous administration and tolerability of drug therapies. Delivering medicines just once- or twice yearly to prevent and/or chronically treat diseases holds potential to improve outcomes by improving effectiveness over time and by addressing real-world unmet needs around poor patient adherence and persistence rates that are high in the majority of chronic diseases. Intarcia is investigating multiple therapies, including combination therapies, for chronic diseases leveraging the convergence of novel medicines and the proprietary medici drug delivery system. Intarcia is developing a strong pipeline in important therapeutic areas, including: diabetes, obesity, autoimmune diseases, HIV, and other serious disorders.