Delivery Device Continues To Be Intarcia’s Downfall Ahead Of FDA Panel On Nonapproval of Implantable GLP-1

 
• By Sarah Karlin-Smith
  
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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.

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Mode of delivery was meant to be a selling point but instead is one of Intarcia’s ITCA 650’s biggest challenges to FDA approval • Source: Shutterstock

Intarcia Therapeutics, Inc.’s attempt to address adherence issues with type 2 diabetes treatments by delivering a formulation of GLP-1 receptor agonist exenatide via an implantable device received yet another unfavorable assessment from the US Food and Drug Administration, as agency reviewers argue the company has not shown any unique benefit associated with the drug-device combination product. Instead, the device may be contributing to increased safety concerns compared to other formulations and delivery methods of drugs in the same class.

FDA’s Endocrinological and Metabolic Drugs Advisory Committee will vote on 21 September on whether the benefits of the drug-device implant,...

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