Another setback for implantable GLP-1 as FDA panel cites safety, delivery concerns

The road to approval for implantable diabetes therapy ITCA 650 just got longer, after an FDA advisory committee unanimously voted that the therapy’s benefits do not outweigh its risks, at least not without another study. But even if i2O Therapeutics Inc. was able to address the outstanding questions about the therapy’s renal and cardiovascular safety, it is difficult to envision the product successfully competing with the leading GLP-1R agonists on the market.

On Thursday, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 0-19, with no abstentions, against the risk-benefit profile of ITCA 650 in patients with Type II diabetes. ...