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Algeta & Bayer granted EU marketing authorization

Algeta and Bayer have received marketing authorisation from the European Commission for Xofigo for the treatment of prostrate cancer patients with  bone metastases.

According to Oslo Cancer Cluster, the marketing authorization provides approval for the commercialization of Xofigo in all 28 countries of the EU, and in Norway, Iceland and Liechtenstein following national approval. The decision is following a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in September of this year.

Xofigo is an alpha particle-emitting pharmaceutical. Its active moiety mimics calcium and selectively targets bone, specifically areas of bone metastases, by forming complexes with the bone mineral hydroxyapatite. The high linear energy transfer of alpha emitters (80 keV/micrometer) leads to a high frequency of double-strand DNA breaks in adjacent tumour cells, resulting in a potent cytotoxic effect. Xofigo is approved in the US for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

Algeta and Bayer signed an agreement in September 2009 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 Xofigo globally. Algeta is eligible for royalties and milestones based on Bayer’s sales of Xofigo outside the US, and Algeta US, LLC is co-promoting Xofigo with Bayer in the US.