Prolia denosumab regulatory update

FDA approved a BLA from Amgen for Prolia denosumab to treat osteoporosis in postmenopausal women who are at high risk of fractures or have failed or are intolerant to other available osteoporosis therapy. The approval, which includes a REMS, comes almost 2 months ahead of the July 25 PDUFA date. Last month, the EC also approved the human mAb targeting receptor activator of NF-kappa B ligand ( RANKL; TNFSF11) for the same indication, as well as to treat bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see BioCentury, June 1).

Amgen, which was originally seeking approval in the U.S. to treat and prevent postmenopausal osteoporosis, plans to launch Prolia in the U.S. within the next week. Prolia's wholesale acquisition cost will be $825 per 60 mg injection, which is administered once every six months. Amgen also will implement a long-term observational safety study to assess adverse events and a program to monitor long-term safety of Prolia. ...