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

 
• By Sue Sutter

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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