Intarcia Therapeutics, Inc. submitted its New Drug Application (NDA) to the FDA for ITCA 650 (exenatide via an osmotic mini-pump) for the treatment of type 2 diabetes.
Intarcia Therapeutics, Inc. announced it has submitted its New Drug Application (NDA) to the FDA for ITCA 650 a once or twice-yearly therapy for the chronic treatment of type 2 diabetes. (T2D). If approved, ITCA 650 would become the first and only injection-free glucagon-like peptide-1 (GLP-1) receptor agonist therapy. ITCA 650 provides consistent and continuous subcutaneous delivery of exenatide via an osmotic mini-pump placed just under the skin in a simple in office procedure that only takes a healthcare provider a few minutes to perform.
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. Twelve-month mini-pumps at the 60mcg/day maintenance dose are also in development.
FREEDOM trial is a global clinical trial development program made up of four Phase III studies of ITCA 650 (continuous subcutaneous delivery of exenatide) for the treatment of type 2 diabetes (T2D). The FREEDOM-1, FREEDOM-1 HBL, FREEDOM-2, and FREEDOM-CVO trials were successfully completed and met all primary and secondary endpoints. Results include demonstrating superior efficacy versus placebo and versus market leader, Januvia (sitagliptin). The overall FREEDOM program enrolled more than 5,000 subjects at over 500 clinical investigation sites in more than 30 countries to support U.S., EU and ROW regulatory filings.
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