Plus   Neg

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Brazos Electric Power Cooperative Inc., the largest power generation and transmission cooperative in Texas, filed for Chapter 11 bankruptcy protection citing a huge bill from the state's grid operator following major outages recently amid the winter storm. Brazos received a $1.8 billion bill from electricity grid operator Electric Reliability Council of Texas or ERCOT. El Abuelito Cheese is recalling certain types of cheese and cheese products for fear of potential contamination with Listeria Monocytogenes, a deadly bacteria, the U.S. Food & Drug Administration said in a statement. The recall involves Queso Fresco (Fresh, soft cheese), Quesillo (Oaxaca, string cheese), and Requeson (Ricotta) products. Technology company CAE Inc. (CAE.TO, CAE) agreed Monday to acquire the military training division of aerospace and defense technology firm L3Harris Technologies Inc. (LHX) for $1.05 billion, subject to customary adjustments. The acquisition will expand CAE's position as a platform-agnostic training...
Follow RTT