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# Intarcia Agrees to Advisory Committee to Resolve Review Dispute
- URL: https://www.fdaweb.com/intarcia-agrees-to-advisory-committee-to-resolve-review-dispute/
- Published: 2023-02-21T12:00:00.000Z
- Updated: 2026-09-14T18:16:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153822

Intarcia Therapeutics has accepted a proposal ([see earlier story](https://www.fdaweb.com/fda-offers-advisory-committee-hearing-on-intarcia-dispute/)) from FDA chief scientist **Namandjé N. Bumpus** to allow an advisory committee to review and address a 2021 CDER decision not to approve the company’s NDA for ITCA 650 (exenatide in DUROS device), a drug/device combination product intended to deliver exenatide, a GLP-1 receptor agonist, as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes. In a 2/20 [citizen petition](https://downloads.regulations.gov/FDA-2023-P-0575-0001/attachment%5F1.pdf?ref=fdaweb.com) submitted by Hogan Lovells, the company accepted the agency’s proposal to schedule an advisory committee meeting within 120 days or as soon as practicable.

The petition acknowledges that FDA and the company have “identified numerous disputes between the parties” regarding the NDA. When CDER rejected the NDA in 2021, it published a *Federal Register* [**notice**](https://www.govinfo.gov/content/pkg/FR-2021-09-02/pdf/2021-18928.pdf?ref=fdaweb.com) that outlined the following issues raised in two complete response letters:

- the clinical trial data demonstrated that the product causes acute kidney injury;
- the cardiovascular risk assessment failed to provide sufficient assurance that ITCA 650 is not associated with excess cardiovascular risk;
- the data provided to validate the limits of the in vitro dose delivery specifications did not support the safe and effective use of the device constituent in the product;
- the data provided, inclusive of delivery performance data and failure analyses, did not demonstrate adequate device reliability associated with in vitro dose delivery to support safety and effectiveness for the intended use;
- the information provided was inadequate in support of sterility assurance for ITCA 650; and
- an FDA inspection of the Intarcia manufacturing facility identified deficiencies in the manufacturing practices for ITCA 650 that were not adequately addressed.