FDA to Review Injection-Free GLP-1 Receptor Agonist Therapy for T2D

The NDA was supported by data from the 'ITCA 650 FREEDOM' Phase 3 clinical trial
The NDA 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).

The NDA was submitted on November 20, 2016, which was supported by data from the successfully completed ITCA 650 FREEDOM global Phase 3 clinical trial program. 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.

For more information visit Intarcia.com.