BayerHealthCare submits Alpharadin to EMA for treatment of castration-resistant Prostate Cancer
Algeta ASA announces that Bayer HealthCare has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Alpharadin (radium-223 dichloride (radium-223)) for the treatment of castration-resistant Prostate Cancer in patients with bone metastases.
The submission is based on data from the pivotal phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial, which was conducted by Algeta. In the study, radium-223 significantly increased overall survival by 44 percent (HR=0.695, p=0.00007), resulting in a 30.5 percent reduction in the risk of death compared to placebo.
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