As far as prostate cancer is concerned, denosumab is approved for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. This approval does not immediately make the drug available in every European country because those decisions are made by individual nations, but approval by EMEA is a necessary first step before a new drug can be made available anywhere in Europe,
This is the first approval of denosumab by an regulatory agency. Amgen and its partners will now have to convince doctors, patients, and payers that denusumab is a “better” drug than zoledronate (Zometa) and others as an agent to prevent bone loss and fractures in patients being treated with hormonal therapy.
Denosumab was also approved by EMEA for the treatment of osteoporosis in postmenopausal women at increased risk of fractures. Action on denosumab by the US Food and Drug Administration for similar indications is expected in July this year.