Intarcia’s ITCA 650 unlikely to reach diabetes market following second FDA rejection

Following the news that Intarcia has received a second rejection from the Food and Drug Administration (FDA) regarding its subcutaneous osmotic pump implant, ITCA 650, for type 2 diabetes (T2D) patients;

Akash Patel MSc, Pharma Analyst at GlobalData, a leading data and analytics company, offers his view:

“This second FDA rejection leaves the future of Intarcia and its device highly uncertain and it is unlikely that its product will be able to reach the market. Even if ITCA 650 were to make it to market, the delays in approval have given a head-start advantage to marketed GLP-1RAs that were designed to address the issue surrounding poor patient compliance. These competitors include once-weekly injectables such as Eli Lilly’s Trulicity (dulaglutide) and Novo Nordisk’s Ozempic (semaglutide), and the first oral GLP-1RA, Novo Nordisk’s oral semaglutide, Rybelsus.  

“Intarcia’s ITCA 650 provides a continuous release of exenatide, an injectable GLP-1RA indicated for the treatment of T2D. ITCA 650 was previously regarded as a device with the potential to solve poor patient compliance with subcutaneous injectable T2D drugs in the GLP-1RA class. Intarcia’s initial rejection from the FDA was received in 2017, with the complete response letter citing problems regarding manufacturing. However, Intarcia have not yet released the details of the recent complete response letter from the FDA. There is now increasing uncertainty regarding the device’s entry to market.”

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