Astellas Pharma: FDA Grants Fast Track Designation For ASP5354 – Quick Facts

Japan-based Astellas Pharma Inc. (ALPMY) said Wednesday that the U.S. Food and Drug Administration or FDA has granted Fast Track designation for the development of ASP5354, based on non-clinical and clinical data.

ASP5354, an optical imaging agent being developed by Astellas, is being investigated for intraoperative ureter visualization in patients undergoing minimally invasive and open abdominopelvic surgeries.

The company noted that the FDA’s Fast Track Designation Program aims to expedite the development and review of potential treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Astellas Pharma said it expects the ASP5354 Fast Track designation to facilitate development and potentially early clinical availability with faster reviews of the novel agent.

ASP5354 is being developed as a surgical adjunct to lessen the likelihood of iatrogenic ureteral injury or IUI during complex abdominal and pelvic surgeries such as colorectal or gynecologic surgeries.

IUI can result in long-term complications such as ureteral stricture / obstruction, ureteral-vaginal fistulae, acute or chronic renal failure, or sepsis. A survey of more than 2 million surgical cases in the U.S. shows that IUI is accompanied by higher rates of morbidity and, in some cases, mortality.

In a 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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