Merck: FDA Grants Priority Review For SNDA Seeking Approval For WELIREG

(RTTNews) - Merck (MRK) announced the FDA has accepted and granted priority review for a supplemental new drug application seeking approval for WELIREG for the treatment of adult patients with advanced renal cell carcinoma following immune checkpoint and anti-angiogenic therapies. The FDA has set a PDUFA, or target action, date of January 17, 2024.

WELIREG was the first HIF-2a inhibitor therapy approved in the U.S. It is currently approved for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated RCC, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery.

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