In a decisive move, a panel of external advisors to the U.S. Food and Drug Administration (FDA) has voted against the diabetes treatment implant developed by Intarcia Therapeutics due to concerns regarding potential safety risks.
The committee’s unanimous decision, delivered on Thursday, underscored the consensus that the advantages offered by the drug-device combination for treating type 2 diabetes did not outweigh the associated risks. The panel specifically highlighted the imperative need for additional safety data to address these concerns.
This verdict follows two prior rejections by the health regulatory authority, both of which were attributed to the potential risks of acute kidney injury (AKI) and cardiovascular complications associated with the drug. It’s worth noting that while the FDA generally adheres to the recommendations of its expert panel, it retains the discretion to make independent decisions.
In briefing documents released on Monday, the FDA’s staff reviewers identified a noteworthy “imbalance” in the occurrence of AKI issues within the treatment group compared to the placebo group.
The diabetes treatment in question, known as ITCA 650, resembles a matchstick in size and employs a subcutaneously implanted pump to administer exenatide, the active ingredient also found in AstraZeneca’s Bydureon. This continuous drug delivery system is designed to manage type 2 diabetes over an extended period, potentially up to a year.
Robert Greevy, a member of the FDA panel, acknowledged that the device had the potential to be a groundbreaking innovation when functioning optimally. Nevertheless, he emphasized that the data presented did not provide sufficient conviction that this version of the device was the most reliable option.
Exenatide belongs to a class of drugs known as GLP-1 receptor agonists, which play a pivotal role in regulating blood sugar levels in type 2 diabetes patients, alongside their appetite-suppressing and satiety-promoting effects. These drugs have also found significant utility as weight-loss treatments, experiencing robust demand in the United States.
Intarcia, once hailed as a biotech unicorn, currently operates as a subsidiary under the privately held i2o Therapeutics.
