Manufacturing Issues Force The FDA To Reject Intarcia's Diabetic Drug Pump
Published: Sep 28, 2017
- Intarcia Receives Complete Response Letter from the FDA for ITCA 650
Company Is Working Closely with FDA on Next Steps and Path Forward
BOSTON, Sept. 27, 2017 /PRNewswire/ -- Intarcia Therapeutics, Inc., a privately held biopharmaceutical company committed to developing innovative therapies to enhance treatment and prevention outcomes in serious chronic diseases, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for ITCA 650 (exenatide implant) for the treatment of type 2 diabetes. The Company looks forward to meeting with the FDA and working closely together on next steps. Intarcia does not anticipate the need to conduct new pivotal trials or any long lead-time CMC activities in order to satisfy the requirements of the FDA. The Company received clear and constructive guidance from the Agency regarding manufacturing aspects of the CRL and is on a clear path to move forward.
"Real-world outcomes data consistently demonstrate that the majority of patients living with type 2 diabetes struggle to adhere to chronic pills and injections. Diabetes remains a devastating public health crisis that is still spiraling out of control because of poor control and poor adherence issues," said Kurt Graves, Intarcia's Chairman, President and CEO. "We remain confident in the approvability of ITCA 650, and have an unwavering commitment to bring forward a new category of medicines that are fundamentally designed to address major unmet needs in diabetes and other serious chronic diseases."
Intarcia remains in a strong fiscal position, with excellent long-term shareholders. The Company's current Series EE equity financing has raised over $600M through September 2017. In addition, the Company has multiple near-term milestones expected from its ex-US collaboration.
For additional updates regarding recent clinical trials data for ITCA 650, pipeline progress, and changes recently made to Intarcia's Board of Directors please visit the company's website.
About Intarcia Therapeutics, Inc.
Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapies to enhance treatment outcomes and prevent chronic disease by optimizing and improving the efficacy, continuous administration and tolerability of drug therapies. Delivering medicines just once- or twice yearly to prevent and/or chronically treat diseases holds potential to improve outcomes by improving effectiveness over time and by addressing real-world unmet needs around poor patient adherence and persistence rates that are high in the majority of chronic diseases. Intarcia is investigating multiple therapies, including combination therapies, for chronic diseases leveraging the convergence of novel medicines and the proprietary Medici Drug Delivery System. Intarcia is developing a strong pipeline in important therapeutic areas, including: diabetes (ITCA 650), obesity, autoimmune diseases, HIV prevention, and other serious disorders.
Intarcia Therapeutics, Inc.
Intarcia Therapeutics, Inc.
SOURCE Intarcia Therapeutics, Inc.