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Merck's Belzutifan Wins FDA Approval As First Drug For Rare VHL Tumors

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  • The FDA on Friday approved Merck & Co Inc's (NYSE: MRK) belzutifan for patients with the rare disorder known as von Hippel-Lindau (VHL) disease.

  • VHL is a rare genetic disease that causes tumors and cysts to grow throughout the body.

  • Belzutifan was one of the most lucrative assets Merck picked up through its 2019 Peloton buy.

  • The FDA's decision comes well ahead of the expected September 15 action date, and it includes a surprisingly broader label beyond just renal cell carcinoma patients.

  • Belzutifan, marketed as Welireg, is intended for VHL patients who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors but don't immediately require surgery.

  • The drug blocks HIF-2α (hypoxia-inducible factor-2 alpha), a protein that plays a role in regulating tissue oxygen levels.

  • Proteins known as hypoxia-inducible factors, including HIF-2α, can accumulate in patients whose bodies don't correctly regulate them, leading to the proliferation of red blood cells and, eventually, cancers.

  • Price Action: MRK shares closed higher at 0.89% at $76.72 on Friday.

  • Related content: Benzinga's Full FDA Calendar.

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