FDA underscores quality, safety concerns with Intarcia’s diabetes treatment ahead of adcomm

After being rejected twice by the FDA in the past six years, Intarcia Therapeutics’ drug-device product to treat type 2 diabetes will be the subject of an advisory committee meeting tomorrow.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will convene to discuss and vote on whether the benefits of Intarcia’s ITCA 650 outweigh the risks. Intarcia sought FDA approval in 2017 and 2019, but was denied both times over quality concerns and clinical deficiencies.

The combo product is inserted subdermally in the abdominal wall and it continuously releases a GLP-1 receptor agonist, exenatide, over the course of six months.

In briefing documents posted ahead of the meeting, FDA underscored its concerns about acute kidney injury, major adverse cardiovascular events, and serious adverse events. The agency also identified deficiencies in the product that could lead to an inconsistent release of exenatide.

The advisory committee meeting comes after i2o Therapeutics acquired Intarcia’s clinical metabolic pipeline, including ITCA 650.

Kurt Graves

Kurt Graves, the former Intarcia CEO who’s now CEO of i2o, argued in comments ahead of the meeting that the FDA has cleared a handful of other GLP-1 drugs, including Novo Nordisk’s Ozempic and Wegovy, in spite of acknowledging the risk of acute kidney injury.

“The hearing upcoming has AKI as the central issue for the GLP-1 class and ITCA 650 and it is a tremendous opportunity to simply assess the facts, acknowledge a class effect risk associated with GI AEs and dehydration, and then agree on what we can all do to further improve the benefit/risk profile of all GLP-1 products,” Graves wrote. “Given the stunning growth of this class of medicines, this is mission-critical to get in front of.”

FDA is asking the committee to vote on the question: “Based on the available data has the Applicant demonstrated that the benefits of the ITCA 650 drug-device combination product outweigh its risks for the treatment of T2DM?”

Advisors will be asked to explain their rationale either way, and, if they vote no, offer thoughts on what additional data could be provided to demonstrate that the benefits outweigh the risks.

In July 2022, FDA’s CDER issued a proposed order to deny approval of ITCA 650. Intarcia then requested an advisory committee meeting on the drug in lieu of a formal evidentiary hearing, a request that FDA Chief Scientist Namandjé Bumpus granted.

Bumpus indicated in a February letter this year that she will make the final decision on whether to approve the product, FDA wrote in its briefing documents.

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