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Intarcia Appeals Advisory Committee On Diabetes Drug-Device Combo, Claiming ‘Misrepresentation’

 
• By Brenda Sandburg

Company contends US FDA gave the committee ‘materially false and misleading information’ about ITCA 650 exenatide implant and did not focus on GLP-1 comparative claims as it seeks a hearing before the commissioner following the panel’s unanimous vote against the application.

Appeal filing
Intarcia appeals the decision of FDA advisory committee that benefits of its diabetes treatment do not outweigh its risks. • Source: Shutterstock

Intarcia Therapeutics, Inc. is continuing its battle with the Center for Drug Evaluation and Research claiming that the unanimous advisory committee vote against its ITCA 650 drug-device combo for treatment of diabetes was based on false and misleading presentations by CDER, including data on the performance of the device.

Such an appeal is unusual, as was the meeting itself, and the company’s effort is likely to be rejected given FDA’s strong concerns about the new drug application going back...

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