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PRINCETON, N.J.--(BUSINESS WIRE)--Sep 28, 2022--
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the U.S. Food and Drug Administration (FDA) has authorized an extension of the in-use period for JELMYTO ® (mitomycin) for pyelocalyceal solution admixture from 8 hours to 96 hours (four days) following reconstitution of the product. This extension is significant and has implications for all stakeholders including physicians, hospitals, pharmacists and the adult patients who use UroGen’s medicine to treat low-grade, upper-tract urothelial cancer (LG UTUC).
“We strive to improve the care of patients who depend on our cancer therapy and that includes streamlining logistics that can have a significant impact on the delivery, storage and timing of treatment,” said Jeff Bova, Chief Commercial Officer, UroGen. “This extension expands access to JELMYTO and gives our customers greater flexibility in choosing when to mix and schedule instillations. It also prepares us for managing future growth based on increased patient volume.”
UroGen encourages healthcare providers to consult the new Prescribing Information and speak to their UroGen representative about this extended in-use period to optimize flexibility when treating patients with JELMYTO.
“This label change for JELMYTO gives physicians and patients the option to treat in the morning, whereas, in most cases, the afternoon was the only option before the change,” explains Rian Dickstein, M.D., Chairman of Urology, University of Maryland Baltimore Washington Medical Center (UM BWMC). “Previously, centers with mixing partners had to have JELMYTO mixed and sent by courier in the morning, now this extension provides added convenience of opening up additional scheduling options, which is very important as it enables us to more efficiently manage patient care.”
About LG UTUC
LG UTUC is a rare disease managed by endoscopic methods and radical nephroureterectomy. Endoscopic resection and laser ablation attempt to preserve the kidney, though there is a high risk of recurrence that may eventually necessitate removal of the kidney. Although kidney removal is the gold standard for treatment of high-grade UTUC, it may be over-treatment in LG UTUC, as kidney removal offers similar five-year survival as kidney-sparing procedures but is associated with significant morbidity. JELMYTO is efficacious as a primary chemoablative therapy in patients with LG UTUC.
About JELMYTO ®
JELMYTO ® (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for primary chemoablative treatment of LG UTUC in adults. It is recommended for primary treatment of biopsy-proven LG UTUC in patients deemed appropriate candidates for renal-sparing therapy. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.
APPROVED USE FOR JELMYTO
JELMYTO ® is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).
IMPORTANT SAFETY INFORMATION
You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:
Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose.
Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.
How will I receive JELMYTO?
After receiving JELMYTO:
JELMYTO may cause serious side effects, including:
The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.
You are encouraged to report negative side effects of prescription drugs to the U.S. Food and Drug Administration. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.
Please see JELMYTO Full Prescribing Information, including the Patient Information, for additional information
About UroGen Pharma Ltd.
UroGen is biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel™ reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. UroGen’s first commercial product JELMYTO (mitomycin) for pyelocalyceal solution, and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer, are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.urogen.com to learn more or follow us on Twitter, @UroGenPharma.
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the implications of the extension of the in-use period for JELMYTO for all stakeholders, including preparing UroGen for managing future growth based on increased patient volume and increasing patient volume; the impact of streamlined logistics on the delivery, storage and timing of treatment; RTGel’s potential to improve the therapeutic profiles of existing drugs; and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: any negative effects on UroGen’s business, commercialization and product development plans caused by or associated with COVID-19; UroGen’s ability to efficiently and effectively manage growth; potential safety and other complications from JELMYTO; the timing and success of clinical trials and potential safety and other complications thereof; the ability to obtain and maintain regulatory approval; the labelling for any approved product; the scope, progress and expansion of developing and commercializing UroGen’s product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Form 10-Q filed with the SEC on May 10, 2022 and other filings that UroGen makes with the SEC from time to time (which are available at http://www.sec.gov ), the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.
View source version on businesswire.com:https://www.businesswire.com/news/home/20220928005322/en/
CONTACT: INVESTORS:
Vincent Perrone
Sr. Director, Investor Relations
vincent.perrone@urogen.com
609-460-3588 ext. 1093MEDIA:
Cindy Romano
Director, Corporate Communications
cindy.romano@urogen.com
609-460-3583 ext. 1083
KEYWORD: UNITED STATES NORTH AMERICA NEW JERSEY
INDUSTRY KEYWORD: BIOTECHNOLOGY FDA HEALTH PHARMACEUTICAL ONCOLOGY
SOURCE: UroGen Pharma Ltd.
Copyright Business Wire 2022.
PUB: 09/28/2022 08:00 AM/DISC: 09/28/2022 08:03 AM
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