Merck (NYSE: MRK) shares decreased in price Friday, on word the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the conditional approval of WELIREG® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor, as monotherapy for:
• The treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated, localized renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), and for whom localized procedures are unsuitable;
• The treatment of adult patients with advanced clear cell renal cell carcinoma (RCC) that progressed following two or more lines of therapy that included a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and at least two vascular endothelial growth factor (VEGF) targeted therapies.
The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union (EU), and a final decision is expected in the first quarter of 2025.
“Today’s positive CHMP opinion brings us closer to offering WELIREG, a first-in-class HIF-2a inhibitor, to certain patients in the European Union, in order to help address critical gaps in care for these patients,” said company official Dr. Marjorie Green. “We are committed to providing innovative treatment options that address serious unmet needs for patients globally and look forward to the European Commission’s decision.”
MRK shares dipped 35 cents to $100.90.
