EC approves Prolia

The European Commission approved Prolia denosumab from Amgen Inc. (NASDAQ:AMGN) to treat osteoporosis in postmenopausal women at increased risk of fractures and to treat bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. Amgen said this is the first approval worldwide of the human mAb targeting receptor activator of NF-kappa B ligand ( RANKL; TNFSF11).

In February, FDA accepted a BLA resubmission from Amgen for Prolia to treat postmenopausal osteoporosis and assigned a PDUFA date of July 25. Amgen has also received complete response letters for BLAs for Prolia to prevent menopausal osteoporosis and to treat and prevent bone loss due to hormone ablation therapy in breast and prostate cancer patients. This month, Amgen also submitted a BLA to FDA for Prolia to reduce skeletal related events in cancer patients. ...