UroGen Pharma Receives FDA Fast Track Designation for MitoGel

UroGen Pharma (URGN) said the U.S. Food and Drug Administration (FDA) has granted fast track designation for the company’s lead product candidate MitoGel to treat low-grade upper tract urothelial carcinoma (UTUC).

“Fast Track designation will help potentially expedite the future regulatory review of MitoGel so we can execute on our goal of bringing this innovative product candidate to market as rapidly as possible,” said Arie Belldegrun, chairman of UroGen.

The FDA’s Fast Track Program is designed to facilitate the development and expedite the review of new drugs to treat serious conditions and fill an unmet medical need. There are currently no drugs approved by the FDA for the treatment of UTUC. The current treatment of UTUC involves endoscopic surgical resection of visible cancer or complete removal of the affected kidney and ureter; however, this is associated with a high rate of disease recurrence.

MitoGel is currently being evaluated in an ongoing phase 3 clinical trial in patients with low-grade UTUC.

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