Intarcia Therapeutics provides regulatory updateFDA accepts resubmitted new drug application for ITCA 650
Intarcia Therapeutics provides regulatory update — FDA accepts resubmitted new drug application for ITCA 650
BOSTON, Mass., October 8, 2019 — Intarcia 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.
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that ITCA 650 may not receive regulatory approval and, if approved, whether ITCA 650 will be commercially successful. No forward-looking statement can be guaranteed. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by federal securities law, Intarcia undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.