Intarcia Therapeutics, Inc.
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Latest From Intarcia Therapeutics, Inc.
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.
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.
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.
The US FDA is free from the need to reconsider Accelerated Approvals in a formal hearing in front of an advisory committee. But now the agency is now trying that approach to hear an appeal of a rejected application.
- Specialty Pharmaceuticals
- Controlled Release
- Implantable Devices
- Large Molecule
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