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The EMA Committee for CHMP recommends the approval of Xofigo in Europe.
Algeta ASA reported that Bayer has received a positive opinion from the EMA Committee for Medicinal Products for Human Use (CHMP) recommending approval of Xofigo (radium Ra 223 dichloride) in Europe. The proposed indication is for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. The decision of the European Commission on the approval is expected in the fourth quarter of 2013.
Xofigo injection was approved by FDA 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 US at licensed facilities.
In September 2009, Algeta signed an agreement with Bayer for the development and commercialization of Xofigo. Under the agreement, Bayer will develop, apply for health authority approvals worldwide, and commercialize Xofigo globally. Algeta is eligible for royalties and milestones based on Bayer's sales of Xofigo outside the US, and Algeta US, is co-promoting Xofigo with Bayer in the US.
Source: Algeta ASA