Intarcia faces FDA refusal to approve as push to get diabetes delivery system to market enters endgame

Intarcia’s implant (Intarcia)

Intarcia Therapeutics has hit another roadblock at the FDA in its effort to win approval for a GLP-1 delivery system. After issuing two complete response letters and denying three dispute resolution requests, the FDA now plans to refuse to approve Intarcia’s filing for approval in Type 2 diabetes.

Boston-based Intarcia raised more than $1 billion on its route to the FDA but has been hit by a series of setbacks since filing for approval of a small implant designed to deliver the GLP-1 receptor agonist exenatide. The FDA issued complete response letters in 2017 and 2020 in response to two requests for approval.

In a Federal Register notice (PDF), the FDA set out events since the second rejection. Intarcia submitted three formal dispute resolution requests last year, all of which were denied by the FDA. The FDA also denied a request for an advisory committee meeting.   

Intarcia responded by submitting a request for a hearing on whether there are grounds for denying approval of the new drug application. The FDA plans to issue an order refusing to approve the filing because of concerns about the safety of the candidate and issues with its production.

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The proposal puts the ball in Intarcia’s court. If Intarcia wants to keep pursuing the matter, it needs to ask for a hearing and provide information to justify its request. The request will be granted if there is “a genuine and substantial issue of fact that requires a hearing to resolve,” the FDA wrote. As the FDA sees it, that means Intarcia’s request needs to address its criticisms of the submission.

Some of the criticisms, which the FDA lays out across several pages, relate to the delivery system. The FDA said the “in vitro device performance data demonstrated inconsistent day-to-day drug delivery,” contributing to the FDA’s conclusion that the evidence doesn’t support the safe and effective use of the device.