Drugs

Bumpus Refuses to Approve Intarcia NDA

FDA principal deputy commissioner Namandjé Bumpus has issued an order refusing to approve an NDA submitted by Intarcia Therapeutics for ITCA 650 (exenatide in DUROS device). The order says FDA determined that the approval criteria have not been met because Intarcia failed to demonstrate that ITCA 650 is safe for its intended conditions of use.

A Federal Register notice says Intarcia proposed that the novel drug-device combination be indicated as an adjunct to diet and exercise to improve glycemic controls in adults with Type 2 diabetes. The company submitted its NDA on 11/21/2016 supported by three Phase 3 trials. CDER issued a complete response letter on 9/21/2017 and the company resubmitted the NDA on 9/19/2019, drawing a second complete response letter that described specific deficiencies and, where possible, recommended ways Intarcia might remedy the deficiencies.

Intarcia pursued formal dispute resolution and submitted a request for a hearing. In a notice of opportunity for a hearing, CDER highlighted six deficiencies with the NDA, Bumpus says in her order, finding that the clinical trial data raised concerns that ITCA 650 causes acute kidney injury and that the cardiovascular risk assessment failed to provide sufficient assurances that ITCA 650 is not associated with excess cardiovascular risk.

Intarcia requested a hearing, Bumpus writes, and argued that the risks identified by CDER were in line with the risks of the product class, rather than being unique to ITCA 650 and thus it could be approved with appropriate labeling restrictions.

CDER submitted a proposed order denying the hearing request, saying that the company had failed to raise a genuine and substantial issue of fact justifying a hearing. Intarcia responded to the CDER proposed order and on 2/7/2023 the Office of the Commissioner offered the firm an opportunity to request a hearing before the Endocrinologic and Metabolic Drugs Advisory Committee. Intarcia requested that hearing on 2/20/2023 and it was held on 9/21/2023. The committee voted unanimously that Intarcia had not demonstrated that its product’s benefits outweighed the risks.

Intarcia submitted exceptions to the committee’s votes and advice, moving the issue before the principal deputy commissioner on appeal.

“While Intarcia correctly points out in its appeal that more therapies are needed for patients with Type 2 diabetes,” Bumpus writes, “FDA will only approve NDAs when the data shows that the benefits outweigh the risks. After reviewing the information contained in the public record, the principal deputy commissioner finds that the benefits of ITCA 650 do not outweigh its risks.” She said she agreed with the advisory committee’s conclusions and also said there are too many unanswered questions regarding risks associated with the treatment to find that it has a positive benefit-risk profile and is safe.

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