New Type 2 Treatment Seeks FDA Approval
Diabetes has become a fast-growing epidemic over recent years, with nearly 10 percent of the U.S. population living with the condition. As a result, pharmaceutical and medical technology companies have doubled down on their efforts to provide for this growing population – but when it comes to technology, most developments are created with type 1 patients in mind.
But with Boston-based startup Intarcia, that might begin to change. Last week, Intarcia filed an application with the FDA for approval of a product that has long been hoped for: an implant meant to treat type 2 diabetes.
The Type 2 Implant
Intarcia has partnered with French pharmaceutical company Servier in this technological endeavor. Their product, called the ITCA 650, is a matchstick-sized rod which is inserted into the patient's abdomen. Once there, the implant will release small dosages of a drug called exenatide into the bloodstream, helping to regulate blood sugar.
ITCA 650 is designed to respond to the body's insulin production, ensuring that the right amount of medication is released at the right time. Intarcia hopes that the implant will reduce the need for regular injections among type 2 patients, and even help them control blood sugar more efficiently than current medication.
ITCA in Action
The FDA approval comes on the heels of four Phase 3 clinical studies for ITCA 650. Intarcia tested their implant on over 5,000 type 2 diabetic patients over the past year. Ultimately, they found that ITCA 650 was significantly more effective in treating type 2 diabetes than the drug Januvia.
Intarcia CEO Kurt Graves hopes that ITCA 650 will turn the very treatment of type 2 diabetes on its head. “Instead of working on yet another incremental pill or injection,” < ahref="http://www.bizjournals.com/boston/news/2016/11/21/intarcia-files-for-approval-of-diabetes-pump-nets.html">he said in a statement, “[O]ur 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,”
At the moment, ITCA 650 is seeking approval in 3-month and 6-month dosages, but Intarcia hopes to later gain approval for a once yearly implant. And the company shows no signs of slowing down; submission to the FDA triggered $100 million in financing, along with the $215 million Intarcia raised privately.