FDA advisory committee will meet next month 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.
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