Intarcia Therapeutics Provides Regulatory Update - FDA Accepts Resubmitted New Drug Application For ITCA 650
- Category: Proteins and Peptides
- Published on Tuesday, 08 October 2019 14:10
- Hits: 584
BOSTON, MA, USA I October 8, 2019 IIntarcia Therapeutics, Inc., announced today that 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.
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™.
About Intarcia Therapeutics, Inc.
Intarcia Therapeutics, Inc. is a biopharmaceutical company dedicated to improving real-world adherence and real-world outcomes in some of our nation's most costly and devastating chronic diseases by leveraging the convergence of medicines and novel delivery technologies. In addition to ITCA 650, Intarcia plans to advance multiple once or twice-yearly drug/device combination therapies in the Medici Drug Delivery System™ – including emerging dual agonist combination therapies in metabolic diseases. Intarcia's pipeline is comprised of investigational treatment and preventative therapies for diabetes, obesity, NASH and HIV.
SOURCE: Intarcia Therapeutics