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Intarcia Gets Chance For AdComm Review Of ITCA 650; Hearing For Sotagliflozin Shot Down

 
• By Brenda Sandburg

FDA chief scientist encourages Intarcia to request advisory committee review of CDER’s proposal to refuse approval of its drug-device diabetes treatment. CDER again denies Lexicon request for hearing on proposal to deny approval of its SGLT2 inhibitor.

Microphone
FDA advisory committe may consider Intarcia's drug implant application for treatment of type 2 diabetes • Source: Shutterstock

Intarcia Therapeutics, Inc. has the chance to make its case before a US Food and Drug Administration advisory committee as to why the agency should not refuse to approve its new drug application for ITCA 650 (exenatide implant) for treatment of type 2 diabetes.

The company has been in a lengthy dispute with the Center for Drug Evaluation and Research over the risk of acute kidney injury with the product, which the company says is rare and not unique to its GLP-1 receptor agonist

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AMR-Targeting Drug Secures EMA PRIME Designation

 
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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.