Implantable Diabetes Drug-Device Combo From Intarcia Gets Public Hearing

Intarcia Therapeutics will continue its seven-year quest for FDA approval of its drug-device diabetes treatment with an alternative form of hearing — a public hearing before an advisory committee on Sept. 21 to discuss CDER’s refusal to approve the product.

The path to seek approval began in 2016 when the company submitted its NDA for the implantable matchstick-sized pump ITCA 650. The device is implanted in the abdomen and slowly delivers exenatide — also marketed as Bydureon and Byetta — for a potential once-a-year treatment for type 2 diabetes.

Success has eluded the company, however, as in 2017 and in 2020 the FDA issued the company complete response letters citing higher-than-normal risk of acute kidney injury and excessive cardiovascular risk for the drug-device combo.

Once valued at more than $5 billion, the Boston-based privately held Intarcia filed for bankruptcy in November 2020 and liquidated assets in January 2021 while still trying to see ITCA 650 through to approval.

Read the Federal Register notice here.

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