An FDA panel delivered a unanimous 19-0 vote, marking its third consecutive refusal to approve ITCA 650, an innovative experimental drug delivery product designed for Type 2 diabetes management. Developed by Intarcia Therapeutics, a Boston-based pharmaceutical company, ITCA 650 had faced two prior regulatory application rejections in 2016 and 2019. This resounding decision by the FDA panel reflects concerns regarding the product’s risk-benefit profile.
ITCA 650 is a unique implantable drug product that aimed to revolutionize the treatment of Type 2 diabetes. It delivers exenatide, a glucagon-like peptide 1 receptor agonist, providing a sustained and controlled release of the medication. Notably, other GLP-1 receptor agonists like Ozempic, Wegovy, and Mounjaro have successfully secured FDA approval for the management of Type 2 diabetes and weight loss.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee had convened on multiple occasions to evaluate the merits and potential risks associated with ITCA 650. The primary concerns that had led to the product’s previous rejections centered around acute kidney injury and cardiovascular events. While the manufacturer had worked to address these concerns and enhance the safety profile, the panel’s unanimous vote on September 21 underscores their belief that the benefits of ITCA 650 still do not outweigh the associated risks.
This decision serves as a pivotal moment in the ongoing quest to develop innovative treatments for Type 2 diabetes. While ITCA 650’s rejection presents a setback for Intarcia Therapeutics, it underscores the FDA’s commitment to rigorous safety evaluations and its dedication to ensuring that patient well-being remains the top priority in the realm of healthcare innovation. As discussions surrounding the future of ITCA 650 continue, the FDA’s decision carries significant implications for the broader landscape of diabetes management and the development of novel therapeutic approaches.