Public hearing in September for implantable diabetes therapy

Three FDA advisory committees to discuss NDAs or BLAs are on deck for September, including a meeting about the ITCA 650 exenatide implant for diabetes. 

Three years after issuing a second complete response letter to Intarcia Therapeutics Inc. citing a risk of acute kidney injury with use of ITCA 650, the agency will hold a public hearing on Sept. 21. FDA opened a docket proposing formal refusal of approval in late 2021. By then, Intarcia had transferred its assets and IP into an assignment for the benefit of creditors (ABC), and on Monday i2o Therapeutics Inc. announced it had acquired Intarcia’s cardiometabolic pipeline, including ITCA 650. ...