UroGen Pharma Ltd. (Nasdaq: URGN) announced today that the US Food and Drug Administration (FDA) has given filing acceptance for its New Drug Application (NDA) for UGN-101 (mitomycin gel) for treatment of low-grade upper tract urothelial cancer. UGN-101 will be the only drug available for this type of cancer.
UroGen president and CEO Liz Barrett said, "The FDA filing acceptance and granting of priority review for UGN-101 is an important milestone in our mission to pioneer new treatments to improve patient care in specialty cancers and urologic diseases. There is a significant unmet need for a better treatment option for patients with LG UTUC, as the current standard of care involves surgical removal of the kidney or repetitive endoscopic tumor removal."
The FDA grants priority review to applications for medicines that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. Priority review designation shortens the review period from the standard 10 months to six months from the submission of the NDA. The FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of April 18, 2020.
The company is on track for the potential launch of UGN-101 by mid-year 2020. The FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to UGN-101 for the treatment of LG UTUC.
Founded in a technological incubator in Israel, the company is now headquartered in New York. The company's chairman is Prof. Arie Belldegrun, who is currently recovering from coronavirus.
The company has raised $320 million from investors including Mori Arkin, OurCrowd, Pontifax and CHealth Fund. Most of the money was raised on Nasdaq.
Published by Globes, Israel business news - www.globes-online.com - on April 16, 2020
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