Biotech company Amgen’s denosumab (Prolia) treatment for osteoporosis has been approved by the European Commission, the company announced last week.
This approval – for postmenpausal women at increased risk of fractures and for hormone ablation in men with prostate cancer – is the first worldwide for the drug.
Last year an FDA committee also recommended that the monoclonal antibody be approved for certain patients, although it awaits full approval in the US.
Some analysts have predicted multi-billion dollar annual sales for the drug, which is probably Amgen’s best hope for a future blockbuster drug (Reuters). “Amgen (NASDAQ: AMGN) can soon start watching the cash roll in for denosumab,” says Fierce Biotech.