Intarcia Therapeutics announced the U.S. Food and Drug Administration (FDA) has accepted the company's resubmission of its new drug application (NDA) for ITCA 650 (exenatide implant), for the treatment of type 2 diabetes mellitus. Intarcia resubmitted the NDA on September 9th, 2019 and the FDA has recently communicated that it considers the NDA resubmission a complete class 2 response, setting the Prescription Drug User Fee Act (PDUFA) target action date of March 9, 2020.
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If approved, ITCA 650 would represent a new twice-yearly delivery system of a glucagon-like peptide-1 (GLP-1) receptor agonist for maintenance therapy of type 2 diabetes. ITCA 650 is a small match stick-sized osmotic mini pump delivery system placed just beneath a patient's skin in the abdominal area, utilizing Intarcia's proprietary Medici Drug Delivery System™.