European Medicines Agency gives positive opinion for Amgen's osteoporosis drug

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has

Prolia is used to treat Osteoporosis in postmenopausal women who are at an increased risk of fractures. It is also used to treat bone loss associated with hormone ablation in men with prostate cancer.

If the European Commission approves prolia, Amgen could market the drug in all the European Union (EU) member states.

It is estimated that 30 per cent of postmenopausal women in the EU have osteoporosis. The World Health Organization (WHO) has recently identified osteoporosis as a priority health issue along with other major non-communicable diseases.

The drug addresses an important unaddressed medical need, with its ability to significantly reduce fractures at key skeletal sites in the body, noted Roger M. Perlmutter, executive vice president of R&D at Amgen.

Prolia is also under regulatory review in the United States, Switzerland, Australia and Canada.