Injection-Free GLP-1 Receptor Agonist for T2D Under FDA Review

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 (ClinicalTrials.gov 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.

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.

Reference

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. http://www.prnewswire.com/news-releases/intarcia-announces-fda-filing-acceptance-of-new-drug-application-nda-for-itca-650-for-the-treatment-of-type-2-diabetes-300402157.html. Accessed February 7, 2017.

This article originally appeared on MPR