3 February 2017 - Intarcia Therapeutics announced today that the U.S. FDA has accepted for active review its new drug application for ITCA 650, an investigational therapy for the treatment of type 2 diabetes. 

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 20 mcg/day three-month introductory dose and then followed by a 60 mcg/day six-month maintenance dose, which translates to twice-yearly dosing after initiation.

Read Intarcia Therapeutics press release