Bloomberg Law
April 15, 2020, 7:09 PM

FDA Grants Approval of Jelmyto to Urogen Pharma

Luzi-Ann Javier
Luzi-Ann Javier
Bloomberg News

The Food and Drug Administration approved UroGen Pharma’s Jelmyto, the first therapy to treat low-grade upper tract urothelial cancer, the disease affecting the lining of the urinary system.

  • Jelmyto is an alkylating drug that inhibits the transcription of DNA into RNA, stopping protein synthesis and taking away the cancer cell’s ability to multiply
  • The agency approved the drug based on the results of a clinical trial involving 71 patients with low-grade UTUC

To contact the reporter on this story:
Luzi Ann Javier in New York at ljavier@bloomberg.net

To contact the editor responsible for this story:
Chakradhar Adusumilli at cadusumilli@bloomberg.net ...

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