Intarcia’s Ambitious Diabetes Breakthrough Faces Unanimous Adcomm Rejection

In a pivotal moment for diabetes treatment, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee delivered a unanimous vote against Intarcia Therapeutics’ groundbreaking investigational drug-device combination, ITCA 650. The innovative product, designed to revolutionize the management of type 2 diabetes, faced a formidable panel of 19 experts who ultimately concluded that the potential benefits of this implantable device did not outweigh the associated risks, particularly concerning the alarming rate of acute kidney injury observed among the treatment group.

During the advisory committee meeting, panel member Patrick Nachman, Director of the Nephrology and Hypertension division at the University of Minnesota, posed a critical question: Could the presence of the ITCA 650 device exacerbate acute kidney injury, even if it’s triggered by external factors? This inquiry highlighted the overarching uncertainty surrounding the safety profile of ITCA 650, prompting calls for additional data through more extensive trials.

This latest setback marks another chapter in the tumultuous regulatory journey of ITCA 650. The FDA’s initial rejection, embodied in the first Complete Response Letter (CRL) issued in September 2017 due to manufacturing issues, was followed by a resubmission over two years later in October 2019, which the FDA considered as a response to the initial CRL. Despite this, the regulator issued a second CRL in March 2020. In response, Intarcia sought an advisory committee meeting to chart a clearer regulatory path forward.

ITCA 650, powered by Intarcia’s proprietary Medici Drug Delivery System, is a marvel of modern medicine—a matchstick-sized mini osmotic pump designed to provide a continuous six-month delivery of therapeutic molecules just beneath the skin, primarily in the abdominal area. This innovation aimed to reduce injection frequency and enhance patient adherence, offering hope to those managing diabetes.

The active ingredient in ITCA 650, exenatide, belongs to the same drug class as Novo Nordisk’s Ozempic (semaglutide) and Lilly’s Trulicity (dulaglutide)—GLP-1 receptor agonists. Notably, like ITCA 650, Byetta and Ozempic have raised concerns about acute kidney injury, as indicated in their labels.

Once a biotech unicorn, Intarcia and its assets, including ITCA 650, recently found a new home under the ownership of private company i2o Therapeutics, signaling a potential shift in the trajectory of this promising technology.

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