UroGen Pharma has submitted the Chemistry, Manufacturing, and Controls (CMC) section of the new drug application (NDA) to the US Food and Drug Administration (FDA) for UGN-102, to treat urothelial cancers.
UGN-102 for intravesical solution is a new drug formulation of mitomycin. The drug utilises UroGen’s proprietary RTGel technology, which allows for sustained release and prolonged exposure to bladder tissue.
This hydrogel-based formulation aims to treat tumours non-surgically.
UroGen president and CEO Liz Barrett said: “The submission of the CMC portion of the NDA for UGN-102 marks a significant milestone for UroGen and underscores our dedication to advancing innovative therapies for the benefit of individuals grappling with low-grade, intermediate-risk non-muscle invasive bladder cancer.
“We look forward to working closely with the FDA throughout the review process and remain steadfast in our commitment to address unmet medical needs in the uro-oncology space and advance patient care.”
UGN-102 is currently in Phase III development for the treatment of low-grade, intermediate-risk, non-muscle invasive bladder cancer (LG-IR-NMIBC).
The rolling NDA submission for UGN-102 is part of UroGen’s strategy to engage early with the FDA, aiming for a more efficient review.
The company expects to complete the NDA submission this year, with the potential for an FDA decision by the first quarter of next year.
UroGen is optimistic about the ENVISION Phase III study’s durability of response endpoint.
The CMC section is a critical component of the NDA, detailing the drug product’s properties, formulation, manufacturing methods, stability data, and analytical testing methods.
Recently, the company entered into a licensing agreement with medac, a German pharmaceutical company, to develop UGN-103, the next-generation mitomycin-based formulation for urothelial cancers.
UGN-103 will combine the company’s RTGel technology with medac’s licensed mitomycin and will follow the FDA approval and launch of UGN-102.
UGN-103 is expected to be advantageous in terms of production, cost, supply, and product convenience.