Bayer HealthCare's new drug application (NDA) for its radium-223 dichloride investigational oncology compound will receive priority review by the U.S. Food and Drug Administration (FDA).
The application is currently under review for the treatment of castration-resistant prostate cancer (CRPC) patients with bone metastases, Bayer said.
The FDA plans to complete its review within six months of the 60-day filing receipt of the NDA submission, rather than the standard 12-month review.
Radium-223 is not yet approved by the European Medicines Agency (EMA) or other health authorities. Bayer submitted a marketing authorization application to the EMA for radium-223 in December 2012 for the treatment of CRPC patients with bone metastases.
In September 2009, Bayer signed an agreement with Algeta of Oslo, Norway, for the development and commercialization of radium-223. Under the terms of the agreement, Bayer will develop, apply for health authority approvals worldwide, and commercialize radium-223 globally. Algeta will copromote radium-223 with Bayer in the U.S.
