Research & Development
Astellas wins FDA's Fast Track designation for investigational near-infrared fluorescence imaging agent
29 October 2020 -

Pharmaceutical company Astellas Pharma Inc (TSE:4503) reported on Wednesday the receipt of the US Food and Drug Administration's (FDA) Fast Track designation to expedite the development and review of the imaging agent ASP5354 for intraoperative ureter visualization in patients undergoing minimally invasive and open abdominopelvic surgeries.

A survey of more than 2 million surgical cases in the US shows that iatrogenic ureteral injury (IUI ) is accompanied by higher rates of morbidity and, in some cases, mortality and the costs to manage IUI can be exceedingly high.

ASP5354 is a derivative of indocyanine green (ICG) that fluoresces upon excitation with a particular wavelength of near-infrared light. It is primarily and rapidly excreted by the kidneys when administered intravenously and provides the surgeon with visualization of the ureter(s) during surgery through the use of a near-infrared fluorescence (NIR-F) medical device.

In the company's Phase 1 study, ASP5354 was safe and well tolerated at all doses evaluated in healthy volunteers. A Phase 2 study is currently underway to evaluate the safety and efficacy of ASP5354 in patients undergoing colorectal surgery.



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