• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Intarcia Therapeutics takes another run at FDA approval

October 15, 2019 By Sean Whooley

Intarcia TherapeuticsIntarcia Therapeutics said last week that the FDA accepted its new drug application resubmission for ITCA 650 for the treatment of Type 2 diabetes mellitus.

The Boston-based company originally resubmitted the NDA on Sept. 9. FDA told the company that it considered the NDA resubmission a complete class 2 response. The Prescription Drug User Fee Act target action date is set for March 9, 2020, according to a news release.

Using Intarcia’s Medici drug delivery system, ITCA 650, is designed to enable subcutaneous delivery of exenatide using a matchstick-sized osmotic pump placed under the skin in a patient’s abdominal area during an in-office procedure.

The FDA rejected ITCA 650 in September 2017, with Intarcia suggesting that the reason was related to the manufacturing of its implant, saying that it had received “clear and constructive guidance from the agency” regarding the drug-device combination product’s manufacturing.

In February 2018, privately-held Intarcia cut 60 employees and received a clinical hold for two of its ongoing marketing studies, following the FDA rejection months earlier. Approval would make ITCA 650 a new, twice-yearly delivery system of a glucagon-like peptide-1 (GLP-1) receptor agonist for maintenance therapy of Type 2 diabetes.

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Implants Tagged With: FDA, Intarcia Therapeutics

IN CASE YOU MISSED IT

  • Tandem Diabetes Care wins CE mark for Mobi insulin pump with Control-IQ+ technology
  • Glooko adds chief strategy officer to chief medical officer’s title
  • Cordis launches 10,000-patient registry for drug-eluting balloon
  • Senseonics opens $50M public offering, $25M private placement with Abbott
  • Study links Abbott CGM use to lower risk of hospitalizations due to heart complications

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS