Intarcia Therapeutics has submitted its New Drug Application (NDA) for ITCA 650 to the U.S. Food and Drug Administration.
ITCA 650 was developed to treat Type 2 diabetes.
"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," Intarcia President and CEO Kurt Graves said. "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.”
Intarcia’s NDA submission for ITCA 650 coincided with World Diabetes Day, during National Diabetes Month. Both events shed light on Type 2 diabetes, one of the world’s fastest-growing health crises.