Intarcia: FDA advisory committee will meet in September to discuss Intarcia's diabetes drug

An FDA advisory committee will meet on Sept. 21 to discuss Intarcia's twice-rejected type 2 diabetes drug candidate and delivery system. The meeting comes nearly six years after the FDA first rejected Intarcia's candidate, called ITCA 650, as an adjunct to diet and exercise to help adults control their type 2 diabetes. Regulators blamed clinical deficiencies and product quality issues, it was later revealed in a Federal Register notice. Intarcia resubmitted its application in 2019 and received another rejection six months later, citing similar issues. Among those concerns was trial data that "demonstrated that ITCA 650 causes acute kidney injury," according to the notice. Intarcia laid off 60 staffers in the months following the first rejection, and has since seen executives depart (including former CEO Kurt Graves) and shut off the phones at its Boston headquarters. But it hasn't given up on ITCA 650. Earlier this year, the FDA granted Intarcia a public hearing before an adcomm in lieu of a formal evidentiary hearing to discuss a proposal by the Center for Drug Evaluation and Research to refuse ITCA 650's approval. The agency's Endocrinologic and Metabolic Drugs Advisory Committee will meet on Sept. 21 to discuss the safety and efficacy of the candidate in type 2 diabetes. However, CDER has declined requests from Intarcia to be given "at least several hours" for its presentation. Drugmakers are typically given 60 to 90 minutes to present before an adcomm. FDA shuts down Intar­ci­a's re­quests to de­vi­ate from typ­i­cal post-CRL hear­ing process