A Food and Drug Administration advisory committee voted unanimously on Thursday afternoon to reject an appeal for Intarcia Therapeutics' Type 2 diabetes drug-device combination treatment, citing continued safety concerns.
The biotechnology company, which recently morphed into morphed into i2o Therapeutics and pulled in $46 million in funding, had previously received two rejections for the combo, called ITCA 650, based on heart and kidney concerns.
“Overall, the panel acknowledges the work that has gone into ITCA 650 and this innovative approach, but felt that it would be a disservice to our patients to recommend approval with the safety and drug delivery concerns that exist,” Cecilia Low Wang, the chair of the committee, said at Thursday’s meeting.
The FDA isn’t required to follow the recommendation of its advisory commitees, but usually does.
Intarcia has tried for more than a decade to develop and get an approval for ITCA 650, which delivers the drug exenatide, also known as Byetta, into patients. Intarcia was founded in 1995 as BioMedicines Inc., and at one point was valued at nearly $5 billion, with investors such as RA Capital Management, Venrock and the Bill & Melinda Gates Foundation. In August, it announced that it had sold its assets to a private company called i2o Therapeutics.
Intarcia has hailed its developments as a game-changer for diabetic patients who struggle with daily or weekly injections. A Phase 3 trial of the company’s drug-device combo in 2015 found that it bested Merck & Co.’s Januvia on blood sugar lowering.
But other so-called GLP-1 medicines such as Wegovy and Ozempic have also delivered promising results in Type 2 diabetes in recent years, and have seen a surge in popularity due to their weight loss effects.
Federal regulators gave Intarcia a chance to request a public advisory committee hearing for its implant after safety fears led to rejections in 2017 and 2020.
Through its appeal, the company argued how other GLP-1 agonists like Wegovy had shown safety signals too — albeit less pronounced — yet they still received approval. Intarcia also highlighted how its device combo could help patients stay compliant with their medication.
But on Thursday, FDA reviewers expressed lingering concerns about the safety profile of ITCA 650, citing a “lack of sufficient data.”
“The uncertainty of the risk in terms of acute kidney injury and impact on cardiovascular outcome is too much to outweigh the possibility of benefit and gain from the adherence issue,” David Cooke, a member of the advisory committee, said at Thursday’s meeting.
FDA staff also highlighted problems with inconsistent drug delivery from Intarcia's device during Thursday's meeting.
The committee said Intarcia should complete additional studies on cardiovascular and kidney injury risks, and to provide more context around how Intarcia’s combo compares to the trial results seen for other GLP-1 agonists.