An advisory panel of external experts to the U.S. Food and Drug Administration (FDA) has voted against the approval of Intarcia Therapeutics’ diabetes treatment implant due to concerns about potential side effects.
The committee unanimously concluded that the benefits of the drug-device combination for treating type 2 diabetes did not outweigh the associated risks, emphasizing the need for additional safety data.
This decision follows two prior rejections by the FDA, primarily due to concerns about the drug’s potential to cause acute kidney injury (AKI) and cardiovascular risks. While the FDA typically follows the recommendations of its expert panel, it is not obligated to do so.
In briefing documents released earlier in the week, FDA staff reviewers identified an “imbalance” in the number of AKI-related issues reported in the treatment group compared to the placebo group.
The drug-device candidate, known as ITCA 650, is approximately the size of a matchstick and employs an implantable pump to deliver the drug exenatide—also found in AstraZeneca’s Bydureon—continuously for up to a year to treat type 2 diabetes.
Robert Greevy, one of the FDA panelists, noted that when functioning optimally, the device could be revolutionary. However, he stated that the data presented did not sufficiently convince them that this was the best version of the device.
Exenatide belongs to a class of drugs known as GLP-1 receptor agonists, which not only help manage blood sugar in type 2 diabetes patients but also have appetite-suppressing and satiety-promoting properties, making them increasingly popular as weight-loss treatments in the United States.
Intarcia, once hailed as a biotech unicorn, is now a subsidiary of privately-owned i2o Therapeutics.
