Intarcia Therapeutics NDA Filed for Type Diabetes Therapy

Intarcia Therapeutics has submitted an NDA for ITCA 650 (exenatide) for treating Type 2 diabetes. If approved, the drug would become the first injection-free glucagon-like peptide-1 (GLP-1) receptor agonist therapy. It is designed to provide consistent and continuous subcutaneous delivery of exenatide via an osmotic mini-pump placed under the skin in an in-office procedure.

The submission is based on data from the FREEDOM global clinical trial development program made up of four Phase 3 studies of ITCA 650. “The FREEDOM-1, FREEDOM-1 HBL, FREEDOM-2, and FREEDOM-CVO trials were successfully completed and met all primary and secondary endpoints,” the company says. “Results include demonstrating superior efficacy versus placebo and versus market leader, Januvia. The overall FREEDOM program enrolled more than 5,000 subjects at over 500 clinical investigation sites in more than 30 countries...”