Intarcia's NDA tackles glycemic control and poor patient adherence head on
ITCA 650 is the first investigational drug to use Intarcia's disruptive Medici Drug Delivery System to deliver chronic medicines just once or twice yearly.
Intarcia Therapeutics has submitted its New Drug Application (NDA) to the FDA for ITCA 650 for the 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 20 mcg/day 3-month introductory dose and then followed by a 60 mcg/day 6-month maintenance dose. Twelve-month mini-pumps at the 60 mcg/day maintenance dose are also in development.
"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," said Kurt Graves, Chairman, President and CEO of Intarcia.
"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."
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