Advertisement
UroGen Pharma Says FDA Approves Plan For Rolling NDA Submission For UGN-102 From January 2024
(RTTNews) - Biotech company UroGen Pharma Ltd. (URGN) announced Tuesday that it has reached agreement with the U.S. Food and Drug Administration (FDA) on plans for submission of a New Drug Application (NDA) for UGN-102 (mitomycin) for intravesical solution.
The FDA indicated that the current clinical development plan for UGN-102, which includes evaluation of duration of complete response (CR) at 12 months from the pivotal ENVISION trial, will support submission of an NDA for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
The FDA also agreed that the UGN-102 NDA can utilize a rolling review, allowing for early submission of the Chemistry, Manufacturing and Controls (CMC) sections of the NDA, which is planned for January 2024.
If approved, UGN-102 has the potential to introduce a new non-surgical treatment paradigm for LG-IR-NMIBC, a subset of bladder cancer patients characterized by high recurrence rates and the need for multiple surgeries.
The UGN-102 clinical development plan centers around the Phase 3 ENVISION pivotal trial and is supported by robust clinical data from the ATLAS Phase 3 and OPTIMA Phase 2b trials.
UroGen Pharma Files Patent Infringement Lawsuit Against Teva Pharma
Asian Shares Mostly Higher On Trade Deal Optimism, China Trade Data
China Exports Growth Beats Expectations; Imports Drop At Slower Pace
NZ Dollar Falls After China Trade Data
NZ Dollar Falls Against Majors
European Shares Likely To Open On Firm Note As China Exports Beat Expectations
Australian Market Extends Early Gains In Mid-market
