I2o Therapeutics CEO Kurt Graves set out on Thursday to make a case to a panel of the FDA’s expert advisors that the benefits of his company’s twice-rejected implant to treat type 2 diabetes outweigh its risks — but the committee wasn’t convinced.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee concluded in a 19-0 vote that the benefits of Intarcia’s ITCA 650 do not outweigh the risks associated with the drug-device combination product. The advisors largely concurred with the FDA’s existing safety concerns about the treatment, which include the risk of acute kidney injury, major adverse cardiovascular events and other serious adverse events.
The combo product is inserted subdermally in the abdominal wall, and it continuously releases a GLP-1 receptor agonist, exenatide, over the course of six months, after which the implant must be replaced. This contrasts with other GLP-1 drugs on the market that require strict adherence to…
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