UroGen Pharma announces rolling NDA submission for UGN-102 to begin in January

UroGen Pharma announced that it has reached agreement with the FDA on plans for submission of a new drug application, or NDA, for UGN-102 for intravesical solution. The FDA indicated that the current clinical development plan for UGN-102, which includes evaluation of duration of complete response, or 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. The FDA also agreed that the UGN-102 NDA can utilize a rolling review, allowing for early submission of the Chemistry, Manufacturing and Controls, or 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 clinical data from the ATLAS Phase 3 and OPTIMA Phase 2b trials.