Intarcia’s Implantable GLP-1 Gets Unanimous No Vote But Lots Of New Trial Design Advice
A US FDA advisory panel feels there could be a place for Intarcia’s exenatide drug-device combo – if the company is willing to put in the work.
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Delivery Device Continues To Be Intarcia’s Downfall Ahead Of FDA Panel On Nonapproval of Implantable GLP-1
CDER reviewers don’t buy that safety concerns with exenatide implant ITCA 650 are in line with the risks labeled for already approved GLP-1 agonists for type 2 diabetes – even other formulations of the same drug – potentially due to unique considerations associated with Intarcia’s delivery method.
Intarcia Gets Its Hearing: FDA Panel To Weigh Nonapproval Of Diabetes Drug/Device Combo In September
Since the Center for Drug Evaluation and Research is conducting the single-day hearing on the type 2 diabetes treatment ITCA 650 under its usual process for advisory committee meetings, it denied Intarcia’s requests for input on adding ad hoc members and extended presentation time.
If FDA chief scientist grants Intarcia’s request for advisory committee meeting, CDER wants to provide input on issues to be considered. Director Cavazzoni says the novel drug-device combination product does not notify the user of a critical failure or infusion status.