Intarcia's NDA filing for diabetes candidate accepted by FDA

US biotech firm Intarcia Therapeutics says the US Food and Drug Administration has accepted for active review its New Drug Application (NDA) for ITCA 650 (exenatide), an investigational therapy for the treatment of type 2 diabetes (T2D).

Privately-held Intarcia says it looks forward to working closely with the FDA through the review process. If approved, ITCA 650 would become the first and only injection-free glucagon-like peptide-1 (GLP-1) receptor agonist therapy, according to Intarcia.

ITCA 650 provides continuous delivery of exenatide via an osmotic mini-pump placed just beneath a patient's skin in the abdominal wall. It is designed to do this by leveraging Intarcia's innovative and proprietary technology, the Medici Drug Delivery System. In studies, ITCA 650 mini-pumps were given with a 20mcg/day three-month introductory dose and then followed by a 60mcg/day six-month maintenance dose, which translates to twice-yearly dosing after initiation. Exenatide is the active ingredient of AstraZeneca’s type 2 diabetes brands Byetta.