FDA shuts down Intarcia’s requests to deviate from typical post-CRL hearing process

The FDA will go ahead with a regular advisory committee hearing process for battered Intarcia’s twice-yearly type 2 diabetes drug, known as ITCA 650, and it will be the agency’s way or the highway, according to a letter from the FDA responding to requests from the company to change what the FDA says are “typical” processes.

The response from the FDA, writing on behalf of the Center for Drug Evaluation and Research (CDER), was a reply to a May 18 letter from lawyers for the company, asking the agency to “deviate from its typical process at every juncture.”

Since 2021, the company has all but shut down as executive team leaders left after the FDA said in a Federal Register notice that the trial data “demonstrated that ITCA 650 causes acute kidney injury.” But the company hasn’t given up, continuing to hound the agency for meetings and a post-CRL hearing that is now an adcomm despite multiple rejections from the agency.

Namandjé Bumpus

In February, Intarcia submitted a citizen petition for an alternative form of hearing. In March, according to a letter from Bumpus, the agency said it would grant the company an Endocrinologic and Metabolic Drugs Advisory Committee instead of a formal evidentiary hearing.

In a meeting in April, the agency said it would set up an adcomm for the company “consistent with the typical practice for advisory committees,” according to the FDA’s letter. But Intarcia continued to ask for changes to the process in May correspondence.

In the FDA’s letter to the company’s lawyers, the agency said that it would decline several of Intarcia’s demands, including the company be given “at least several hours” for its presentation and allow Intarcia to give “reasonable input on the optimal composition of the committee.”

Intarcia also complained in the letter that the adcomm was scheduled without conferring with them first.

“To the extent, your May 18 Letter asks CDER to deviate from its typical process for convening an advisory committee… CDER declines these requests,” the letter reads, adding that it would schedule a new date for the adcomm “as soon as practicable.”

The lawyers’ letter argued that the 60- or 90-minute time limits were “unreasonable and unworkable given the breadth of issues CDER asserts must be covered and given the intended purpose of the meeting.”

Kurt Graves

In response to a request for comment, Kurt Graves, the former chairman, president and CEO of Intarcia, said in an email to Endpoints News he is “pleased” that the Office of the Commissioner granted the public hearing “to resolve the substantive facts on record in this scientific dispute.”

“The hearing will have relevance to millions of Americans who remain with poorly controlled glucose and the EMDAC will be voting on some very important matters to the diabetes community related to ITCA 650 as well as a very important GLP-1 class effect that is a GLP-1 class-labeled Warnings for rare AKI events that are at the very crux of this scientific dispute,” he added.

Intarcia has unsuccessfully battled with the FDA since 2017 to get ITCA 650 approved. In its first submission, the FDA told the company to address extensive clinical deficiencies and device and product quality-related issues. Then in 2019, Intarcia re-submitted its application, and the FDA issued a second CRL, citing similar issues. The agency also denied three other formal dispute resolution requests along the way.

fda
research