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Intarcia’s Implantable GLP-1 Gets Unanimous No Vote But Lots Of New Trial Design Advice

 
• By Sarah Karlin-Smith

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.

Diabetes
Intarcia’s last ditch attempt to change FDA’s mind on its diabetes implant looks unlikely after negative advisory panel vote • Source: Shutterstock

Intarcia Therapeutics, Inc. looks unlikely to shift the US Food and Drug Administration’s mind on the non-approvability of its drug-device implant for type 2 diabetes following a unanimous 19-0 advisory committee vote that the sponsor failed to demonstrate that the benefits of the combination product outweigh its risks.

But the Endocrinologic and Metabolic Drugs Advisory Committee acknowledged at the 21 September meeting that they could see a potential use case for ITCA 650, which delivers a formulation of GLP-1 receptor agonist exenatide via an implantable device thus potentially offering an adherence benefit, if the product’s current owner, i2O Therapeutics, Inc

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