European Commission grants marketing authorization for Bayer HealthCare's Xofigo injection

Bayer HealthCare announced today that the European Commission has granted marketing authorization for Xofigo^® (radium Ra 223 dichloride) solution for injection for the treatment of adults with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastases. This decision follows a positive recommendation from the European Committee for Medicinal Products for Human Use (CHMP) in September of this year.

Xofigo was approved by the U.S. Food and Drug Administration in May 2013 for the treatment of patients with CRPC, symptomatic bone metastases and no known visceral metastatic disease and is now available in the United States at licensed facilities. The approval of Xofigo is based on data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial.

"As the latest addition to Bayer's growing oncology franchise and following a quick approval in the U.S., we are pleased that Xofigo is now available to patients in Europe," said Kemal Malik, MD, member of the Bayer HealthCare Executive Committee and Head of Global Development.