FDA advisory committee voted unanimously to reject an appeal for Intarcia Therapeutics’ Type 2 diabetes drug-device combination treatment, citing continued safety concerns.

“Overall, the panel acknowledges the work that has gone into ITCA 650 and this innovative approach, but felt that it would be a disservice to our patients to recommend approval with the safety and drug delivery concerns that exist.

The uncertainty of the risk in terms of acute kidney injury and impact on cardiovascular outcome is too much to outweigh the possibility of benefit and gain from the adherence issue,” David Cooke, a member of the advisory committee. FDA staff also highlighted problems with inconsistent drug delivery from Intarcia’s device during Thursday’s meeting.

A private company called i2o Therapeutics announced on 5 September 2023 that it acquired Intarcia’s assets, among them the biotech’s diabetes drug-eluting implant and the technology on which it was built. That treatment, called ITCA 650, helped Intarcia raise more than $1 billion in private financing. At one point, Intarcia held the label of potential game-changer in diabetes. The company developed a type 2 diabetes drug and a proprietary six-month GLP-1 implant for delivery. But the FDA refused to allow Intarcia’s ITCA 650 on the market. Trials identified that it might cause acute kidney issues, while the company ran into some production challenges.