US FDA accepts submission of Amgen's denosumab
This article was originally published in Scrip
The US FDA had accepted Amgen's BLA submission of denosumab, a fully human monoclonal antibody agonist against RANK ligand, for the treatment and prevention of postmenopausal osteoporosis in women, and the treatment and prevention of bone loss in patients undergoing hormone ablation therapy for either prostate or breast cancer. The drug, which is viewed as the next major growth driver for Amgen, was filed with the agency in December (Scrip Online, December 23rd, 2008).
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