Bayer HealthCare announced recently that the company has received the marketing approval for Xofigo by the Norwegian Medicines Agency.
Xofigo (radium Ra 223 dichloride) has been developed by Algeta. In September 2009, the two companies signed an agreement for the further development and commercialization of radium-223. Xofigo is produced in Norway at the Institute for Energy Technology (IFE) at Kjeller, outside Oslo. According to Bayer’s estimations, Xofigo will be available for Norwegian patients during the first months of 2014, reports Oslo Cancer Cluster.
Xofigo was approved by the U.S. Food and Drug Administration in May 2013 for the treatment of patients with CRPC, symptomatic bone metastases. The approval of Xofigo is based on data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial.