BioCentury
ARTICLE | Clinical News

Prolia denosumab regulatory update

September 24, 2012 7:00 AM UTC

FDA approved an sBLA from Amgen for Prolia denosumab to include treatment to increase bone mass in men with osteoporosis at high risk for fracture. Prolia is already approved in the U.S. and EU to treat osteoporosis in postmenopausal women and in the EU to treat bone loss associated with hormone ablation in men with prostate cancer. The human mAb targeting receptor activator of NF-kappa B ligand ( RANKL) is approved in the U.S. and EU as Xgeva to prevent skeletal related events (SREs) in adults with bone metastases from solid tumors. In April, FDA issued a complete response letter for an sBLA for Xgeva to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases (see BioCentury, April 30). ...