FDA Grants Breakthrough Therapy Designation for UroGen Pharma’s UGN-101

UroGen Pharma (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to the Company’s lead product candidate, UGN-101, (mitomycin gel) for instillation.

As quoted in the press release:

UGN-101 is currently in Phase 3 development for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC). Breakthrough Therapy Designation is designed to expedite the development and review of new drugs to treat serious or life-threatening conditions, so patients may have access to therapies through FDA approval as soon as possible. The FDA previously granted both Orphan Drug and Fast Track designations to UGN-101 for the treatment of LG UTUC.

“UGN-101 was developed to provide an effective alternative to current treatment options, that avoids the risks of surgery, anesthesia, and the deleterious effects of kidney removal,” said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. “The Breakthrough Therapy Designation confirms that UGN-101 represents a novel and effective approach to treat this devastating disease, and we look forward to close collaboration with the FDA as we bring this potentially transformative therapy to patients with LG UTUC as quickly as possible.”

Click here to read the full press release.