The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ITCA 650 (Intarcia Therapeutics) for the treatment of type 2 diabetes (T2D). ITCA 650 continuously delivers exenatide via an osmotic mini-pump inserted subcutaneously into the abdominal wall. 

The NDA was submitted on November 20, 2016, which was supported by data from a recently completed phase 3 clinical trial ( Identifier: NCT01455857). Exenatide, the active ingredient in ITCA 650, is currently marketed as a twice-daily and once-weekly self-injection. 

If approved, ITCA 650 would become the only twice-yearly, injection-free glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of T2D.

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ITCA 650 is designed to provide a continuous subcutaneous delivery of exenatide through Intarcia’s innovative technology platform, the Medici Drug Delivery System. Exenatide is continuously and consistently delivered via an osmotic mini-pump placed just beneath a patient’s skin in the abdomen. 

A 3-month initiation dose, followed by consecutive 6-month maintenance doses are delivered, translating to twice-yearly dosing after initiation.

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Intarcia Announces FDA Filing Acceptance of New Drug Application (NDA) for ITCA 650 for the Treatment of Type 2 Diabetes [news release]. Boston, MA: Intarcia Therapeutics, Inc.; February 3, 2017. Accessed February 7, 2017.

This article originally appeared on MPR