The FDA on Thursday issued an order denying Intarcia’s appeal over its rejected type 2 diabetes combo product, ending nearly eight years of back-and-forth on the application.
Intarcia received complete response letters for the product in 2017 and 2020 after initially filing for approval in 2016. Known as ITCA 650, the combo product sought to provide continuous dosing of exenatide from a mini-pump implanted in the abdomen.
Namandjé BumpusIn the order, FDA principal deputy commissioner Namandjé Bumpus noted several safety concerns with ITCA 650, aligning her views with an advisory committee that last year unanimously voted against ITCA 650 and also “expressed a need for more data related to AKIs, cardiovascular risks and overall safety to assess whether ITCA 650 is sufficiently safe for the indicated population.”
The agency previously said that “AKI events experienced by participants who received ITCA 650 sometimes resulted in prolonged hospitalization” and “complications observed in association with AKI events included dialysis and death.”
“While Intarcia correctly points out in its appeal that more therapies are needed for patients with T2DM, FDA will only approve NDAs when the data shows that the benefits outweigh the risks,” Bumpus wrote in the order published in Thursday’s Federal Register.
Kurt Graves, the former CEO of Intarcia — which was acquired a year ago by i2o Therapeutics, where he is now CEO — did not immediately respond to a request for comment. Intarcia was once valued at more than $5 billion and its early investors included the Bill & Melinda Gates Foundation.