Intarcia Submits New Drug Application to FDA for Diabetes Treatment

Intarcia Therapeutics has submitted its new drug application to the FDA for the ITCA 650, the matchstick-size pump that delivers microscopic size doses of exenatide to patients with type 2 diabetes (T2D).

The tiny pump, which is inserted just below the surface of the skin and replaced once or twice a year, has been shown in early trials to improve glycemic control in patients with previously uncontrolled T2D, largely because it overcomes the chief challenge in diabetes care—medication adherence.

Kurt Graves, president and CEO of Intarcia, said in a statement that the company was excited to submit it new drug application so close to World Diabetes Day, which was November 14.

“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,” he said. “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.”

Graves called the ITCA 650 a “disruptive” technology that would change diabetes care with “built-in compliance and adherence.” In presentations at the American Diabetes Association (ADA), leading researcher Julio Rosenstock, MD, brought the same message in presenting clinical trial results: “Persistence means that people don’t just start the medication, but they stay on the medication,” he said at the ADA meeting in June.

In a trial that compared patients taking a daily 60 mcg dose of exenatide with those taking 100 mg of sitagliptin (with both groups taking background metformin), the group taking the exenatide through the ITCA 650 device saw their glycated hemoglobin (A1C) drop 1.5%, on average, compared with 0.8% for the sitagliptin arm. All the patients started with A1C between 7.5% and 10.5%; of those using ITCA 650, 61% achieved an A1C of less than 7%, compared with 42% for the sitagliptin arm. The ITCA 650 patients lost 8.8 pounds, compared with 2.8 pounds for the sitagliptin arm.

Intarcia has also announced topline results showing it has met targets in a cardiovascular (CV) safety trial, but it has not yet presented the results at a major scientific meeting. Exenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist, and another GLP-1, lixisenatide, has announced CV safety results that show no harm but no benefit, while liraglutide (Victoza) has been shown to have some CV benefits.