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FDA grants Alpharadin Fast Track designation

August 23, 2011
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OSLO, Norway — Algeta ASA today announced that Alpharadin (radium-223 chloride) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of castration-resistant (hormone refractory) prostate cancer in patients with bone metastases, according to a press release.

Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need so that important new drugs are available earlier.

“The positive results at the pre-planned interim analysis of the pivotal phase III study, ALSYMPCA, (ALpharadin in SYMptomatic Prostate Cancer) was a great achievement for Algeta and for Bayer, reinforcing the common belief of Alpharadin’s potential to become an important treatment for bone metastases initially with prostate cancer,” said Andrew Kay, Algeta’s president and CEO. “We are pleased that Alpharadin now has been granted Fast Track designation by the FDA, as this represents an important step towards Alpharadin filing which we anticipate mid 2012 ahead of previous expectations.”
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