ITCA 650 is an implantable drug product made by Intarcia Therapeutics, a Boston-based company that was unsuccessful in gaining approval after filing regulatory applications in 2016 and 2019.
The experimental therapy delivers exenatide, a glucagon-like peptide 1 receptor agonist. Other GLP-1s include Ozempic, Wegovy and Mounjaro, which are approved for Type 2 diabetes or weight loss management.
In past meetings among the FDA Endocrinologic and Metabolic Drugs Advisory Committee members, concerns about acute kidney injury and cardiovascular events led to the rejections. On Sept. 21, the advisers said the benefits do not outweigh the risks.
Read more about the experimental therapy’s history here.
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