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Press release content from Business Wire. The AP news staff was not involved in its creation. Merck Receives Priority Review From FDA for New Drug Application for HIF-2α Inhibitor Belzutifan (MK-6482) March 16, 2021 GMT KENILWORTH, N.J. (BUSINESS WIRE) Mar 16, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a New Drug Application (NDA) for the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor belzutifan (pronounced bell-ZOO-ti-fan), a novel investigational candidate in Merck’s oncology pipeline, for the potential treatment of patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC), not requiring immediate surgery. This NDA is based on data from the Phase 2 Study-004 trial, in which belzutifan showed a confirmed overall response rate of 36.1% (n=22/61) (95% CI: 24.2-49.4) in patients with VHL disease-associated

United statesScot ebbinghausRebecca newberryCourtney ronaldoPeter dannenbaumPatrick ryanMerck research laboratoriesDrug administrationStatement of merck co incExchange commissionMerck co incNew drug applicationPrescription drug user fee actMerck researchNobel prizeVon hippel lindau disease