Intarcia’s Exenatide Implant Rejected Again As US FDA Denies Comparative Safety Argument

Principal deputy commissioner Bumpus agrees with advisory committee findings that safety issues with ITCA 650 preclude approval, regardless of comparisons to other diabetes treatments. Final order caps a nearly eight-year regulatory saga that has grown increasingly rancorous.

Closed door
FDA has closed the door to approval of Intarcia's ITCA 650. • Source: Shutterstock

The US Food and Drug Administration appears to have closed the door to further debate on the approvability of Intarcia Therapeutics’s ITCA 650, an exenatide implant for type 2 diabetes.

The drug-device combination product’s benefit-risk profile is inadequate to support approval, Principal Deputy Commissioner (PDC) Namandjé Bumpus said.

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