Amgen Inc. (Nasdaq: AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced a positive opinion for the marketing authorization of Prolia((TM)) (denosumab) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. If approved by the European Commission, Amgen would receive marketing authorization for Prolia in all European Union (EU) Member States.
"Nearly two decades ago, Amgen researchers described a fundamental biochemical pathway that controls bone remodeling," said Roger M. Perlmutter, executive vice president of Research and Development at Amgen. "Armed with this information, our scientists identified a targeted therapy that acts via this normal control mechanism to reduce bone loss. Today's announcement by the CHMP offers the hope that this important new therapy will soon be available to European women with post menopausal osteoporosis, and to European men with prostate cancer who, as a result of hormone ablation therapy, have a significantly increased risk of fracture. With its ability to significantly reduce fractures at key skeletal sites throughout the body, a favorable benefit-risk profile, and convenient dosing every six months, Prolia addresses an important unmet medical need."
The CHMP positive opinion is based on data from six Phase 3 trials. Two Phase 3 pivotal studies with fracture endpoints in the osteoporosis and prostate cancer settings demonstrated that Prolia administered as a subcutaneous injection twice yearly (60mg) reduces the incidence of fractures. All six studies showed Prolia's ability to increase bone mineral density at all skeletal sites measured.