The latest clinical trial results make European approval even more likely for Prolia and give the company additional data to submit to the FDA following their request in October 2009 for supplementary information. Given Prolia could be a $3 billion plus drug by 2013, the trial news are an excellent boost for Amgen.
Tuesday, February 9, 2010
Positive results from Amgen's Prolia in head to head clinical study
Amgen (AMGN) announced after the close last night that a third pivotal phase III clinical trial in 1,900 patients showed that osteoporosis drug, Prolia (denosumab) works better than Novartis's Zometa to delay and reduce the risk of fractures and other bone complications in men with advanced prostate cancer. The shares rose nearly 3% after hours to $59. The company said that the trial met all its primary and secondary goals and that full results would be announced at a medical meeting in June.
The latest clinical trial results make European approval even more likely for Prolia and give the company additional data to submit to the FDA following their request in October 2009 for supplementary information. Given Prolia could be a $3 billion plus drug by 2013, the trial news are an excellent boost for Amgen.
The latest clinical trial results make European approval even more likely for Prolia and give the company additional data to submit to the FDA following their request in October 2009 for supplementary information. Given Prolia could be a $3 billion plus drug by 2013, the trial news are an excellent boost for Amgen.
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