Injection-Free GLP-1 Receptor Agonist for T2D Under FDA Review
The NDA filed wtih the FDA was supported by data from the 'ITCA 650 FREEDOM' phase 3 clinical trial.
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.
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.