UroGen Pharma initiates rolling submission of NDA for UGN-101

UroGen Pharma announced that it has initiated the rolling submission with the U.S. Food and Drug Administration of the New Drug Application for UGN-101 for instillation as a treatment for patients with low-grade upper tract urothelial cancer. The company expects to complete its NDA submission by mid-2019, with potential approval in 2019. The NDA submission is supported by clinical data from the Phase 3 OLYMPUS clinical trial of UGN-101 for the non-surgical treatment of LG UTUC. Results from an interim analysis were presented at the American Urologic Association Annual Meeting in May 2018. UroGen plans to present topline data from the OLYMPUS study in January 2019. The FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to UGN-101 for the treatment of UTUC. If approved, UGN-101 would be the first drug approved for the non-surgical treatment of LG UTUC.
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