Therapy Areas: Central Nervous System
FDA Approves Merck's Hypoxia-Inducible Factor-2 Alpha (HIF-2α) Inhibitor Welireg for the Treatment of Patients With Certain Types of Von Hippel-Lindau Disease-Associated Tumors
13 August 2021 - - The US Food and Drug Administration has approved Welireg, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery, US-based pharmaceutical company Merck (NYSE: MRK) said.

The recommended dose of WELIREG (40 mg tablets) is 120 mg once daily until disease progression or unacceptance toxicity.

The approval is based on results from the open-label Study 004 trial, where the major efficacy endpoint was overall response rate in patients with VHL-associated RCC.
Welireg is the first HIF-2α inhibitor therapy approved in the US As an inhibitor of HIF-2α, Welireg reduces transcription and expression of HIF-2α target genes associated with cellular proliferation, angiogenesis and tumor growth.


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