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# FDA Reviewers Again Nix Intarcia Diabetes Product
- URL: https://www.fdaweb.com/fda-reviewers-again-nix-intarcia-diabetes-product/
- Published: 2023-09-20T12:00:00.000Z
- Updated: 2026-09-14T18:57:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155373

FDA medical reviewers have reiterated their concerns about Intarcia Therapeutics’ implantable ITCA 650 (exenatide in DUROS device) in a briefing document released in advance of a 9/21 meeting of the agency’s Endocrinologic and Metabolic Drugs Advisory Committee that will consider the company’s NDA. The [document](https://docwirenews.com/podcast/drug-shortages-in-the-us-the-fda-perspective-with-robert-califf?ref=fdaweb.com) says the committee is asked to discuss the safety and efficacy of the drug/device combination that is seeking an indication as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes.

CDER has assessed that the NDA is not approvable in its current form because the benefit/risk assessment for the product is unfavorable based on the available data, the reviewers declare. The document says the Center has repeatedly communicated this assessment to the company and in a 3/9/2020 complete response letter recommended that Intarcia “redesign the product such that it provides reliable and clinically appropriate exenatide release rates over the life of the product” and “conduct new clinical trials to demonstrate the efficacy and safety of the redesigned drug/device combination product.”

However, following a CDER 7/29/2022 proposed order to deny approval of the NDA, the company requested a public hearing before an advisory committee, leading to this committee session.

Committee members are asked to discuss their assessment:

- of the product’s safety profile and whether that profile has been adequately characterized based on available data concerning renal, cardiovascular, and overall safety;
- of the benefit/risk balance of ITCA 650 for the indication to improve glycemic control in patients with Type 2 diabetes.