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news.Intarcia Therapeutics has submitted its New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ITCA 650 to treat type 2 diabetes (T2D).
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The NDA submission was made in close proximity to World Diabetes Day, and during National Diabetes month in America – two annual events that remind us that type 2 diabetes is one of the largest and fastest-growing public health crises in the world.
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.
Intarcia chairman, president and CEO Kurt Graves said: “It’s very exciting for us to submit our NDA in close proximity to World Diabetes Day – a day created to drive for new and innovative solutions that respond to the rapidly growing unmet needs and threats facing hundreds of millions of patients and their doctors and payers around the world.
“During the past decade over 40 new pills and injections were approved for diabetes, however, the scary reality is that the majority of patients with type 2 diabetes still have poor glycemic control and poor adherence to their pills and injections over time. These trends and the alarming amount of diabetes complications, costs, and lives lost on a daily basis have to be addressed with a real sense of urgency.
"The crisis in front of us is what inspires us and drives us to innovate and disrupt the way society currently thinks about trying to control chronic diseases with pills and injections. Instead of working on yet another incremental pill or injection, our mission is to open up a totally new and disruptive pathway of delivering effective medicines just once or twice-yearly with built in compliance and adherence. I want to sincerely thank everyone dedicated to this mission with us. We are one big step closer to our first medicine making it to patients and we hope and trust we will have much to celebrate and give back to the diabetes community around World Diabetes Day next year, and for many years to come.”
About the FREEDOM Clinical Trial Program
FREEDOM is a global clinical trial development program made up of four Phase 3 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.
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.
About ITCA 650
ITCA 650 is designed as a once or twice-yearly therapy for the chronic treatment of type 2 diabetes. The investigational therapy employs Intarcia’s innovative technology platform, the Medici Drug Delivery System.
In its Phase 3 clinical trials for type 2 diabetes, ITCA 650 was evaluated while delivering a continuous and consistent drug therapy in a three-month initiation dose, followed by consecutive six-month doses.
Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist that is currently marketed globally as twice-daily and once-weekly self-injection therapies for type 2 diabetes. If approved, ITCA 650 would be the first and only injection-free GLP-1 receptor agonist therapy.