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Bayer's prostate cancer drug fast-tracked

Bayer Healthcare has said its investigational prostate cancer treatment Alpharadin has been fast-tracked for approval by the US Food and Drug Administration (FDA)

Bayer Healthcare has said its investigational prostate cancer treatment Alpharadin (radium-223 chloride), has been fast-tracked for approval by the US Food and Drug Administration (FDA).

The drug, which is licensed from its developers Algeta ASA, is intended for the treatment of castration-resistant prostate cancer in patients with bone metastases.

The FDA's fast track process is designed to accelerate the review of treatments for serious diseases that fill an unmet need. During the process, increased and more frequent communication is encouraged by the FDA, with the extra level of correspondence intended to lead to earlier drug approvals and patient access to treatments.

Dr Kemal Malik, head of global development at Bayer explained there is a "significant unmet need" for patients in advanced stages of the disease.

He said: "We are excited that Alpharadin has achieved this important milestone and recognise this fast track designation as an important step in the overall development of Alpharadin, particularly for those patients in need of treatment."

Bayer holds the global rights to develop and commercialise Alpharadin. However, in the US, Algeta retains an option for co-promotion and profit-sharing.

23rd August 2011

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