FDA Adcomm Votes Down Intarcia’s T2 Diabetes Combo Product

Despite positive and sometimes emotional testimony from diabetes patients, an FDA advisory committee voted Thursday to uphold CDER’s recommendation that the new drug application for ITCA 650 (exenatide in DUROS device), Intarcia Therapeutics’s diabetes drug/device combo, be denied approval.

The adcomm decision is the latest of several regulatory defeats for the product which is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. In September 2017, the FDA issued a complete response letter for the implantable device, citing manufacturing issues, and then rejected the company’s 2020 resubmission.

Continuing its quest for approval, Intarcia sought and was granted a meeting with the adcomm to publicly discuss the product and clarify what they believed were factual errors related to the FDA’s intended rejection.

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