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Following Pre-NDA Meeting with the FDA, UroGen Announces Rolling NDA Submission for UGN-102 to Begin January 2024
PRINCETON, N.J.--(BUSINESS WIRE)-- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that
About this update from Urogen Pharma Ltd.
[{"type":"text","content":" PRINCETON, N.J.--(BUSINESS WIRE)--\nUroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced 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.\n\n\n“We are very pleased with the outcome of our pre-NDA meeting where the FDA agreed with our plan to submit our NDA for UGN-102 once all patients reach 12 months post CR. Our dialogue with the FDA during our recent pre-NDA meeting was very constructive and underscores the strength of our clinical program for UGN-102,” said Liz Barrett, President and CEO, UroGen. “With the announcement of positive Phase 3 topline results from the ATLAS and ENVISION studies earlier this year, this meeting was a significant step in defining the path forward for NDA submission and potential approval for UGN-102. UroGen is committed to developing innovative treatments for those battling bladder cancer, one of the most recurrent malignancies, and UGN-102 stands at the forefront of that mission.”\n\n\nThe 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.\n\n\nAbout UGN-102\n\n\nUGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel® technology, a sustained release, h...