Merck: EU approves WELIREG treatment

(CercleFinance.com) - Merck announced that the European Commission (EC) has conditionally approved WELIREG (belzutifan), the oral factor 2 inhibitor.


WELIREG is the first and only oral hypoxia-inducible factor 2 alpha inhibitor approved in the European Union.

The EC approval of these two indications is based on the results of the LITESPARK-004 and LITESPARK-005 trials, respectively, and follows the positive recommendation of the Committee for Medicinal Products for Human Use adopted in December 2024.

WELIREG is now approved in over 30 countries for certain adult patients with previously treated advanced RCC, and in over 40 countries for adult patients with certain eligible VHL-associated tumors.

' The approval of WELIREG in the EU introduces the first and only systemic treatment option for adult patients with certain VHL-associated tumors for whom localized procedures are not suitable,' said Dr. Marjorie Green, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories.

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