Amgen has received EU marketing approval for Prolia (Denosumab), which is used in the treatment of osteoporosis in postmenopausal women and for the treatment of bone loss associated with hormone ablation in men with prostate cancer.
The European approval of Prolia marks the first approval of the product, which is indicated for men and women at increased risk of fracture.
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Prolia has now been approved in all 27 European Union member states as well as Norway, Iceland and Liechtenstein.
Amgen senior vice-president and international chief Will Dere said that Prolia will offer patients with postmenopausal osteoporosis at increased risk of fracture an important alternative to current treatments.
“Prolia reduces the risk of fracture through a convenient injection given every six months,” Dere said.
Marketing authorisation is based on data from six phase III trials, which demonstrated that Prolia administered as a 60mg subcutaneous injection every six months reduced the incidence of fractures.
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By GlobalDataAll six studies showed Prolia’s ability to increase bone mineral at all skeletal sites measured.
