Merck (MRK) said Tuesday it has received conditional approval from the European Commission for its Welireg drug to treat adult patients with von Hippel-Lindau disease, a rare genetic disorder characterized by the formation of tumors and cysts in certain parts of the body.
Welireg is for those patients with von Hippel-Lindau disease who require therapy for renal cell carcinoma, central nervous system hemangioblastomas or pancreatic neuroendocrine tumors, and for whom localized procedures are unsuitable. The drug is also for those with previously treated advanced renal cell carcinoma, the company said.
Welireg can now be marketed in all 27 European Union member states, as well as Iceland, Liechtenstein, and Norway. The conditional approval of the drug is valid for one year and is subject to yearly renewal, pending additional data from two of Merck's ongoing clinical trials, the company said.
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