Long term data for Prolia in FREEDOM extension trial

Amgen announced new long-term data showing that during the fourth and fifth years of Prolia (denosumab) treatment, postmenopausal women with osteoporosis receiving Prolia continued with further, statistically significant, year-over-year increases in lumbar spine and total hip bone mineral density (BMD), a key measurement of bone strength. The overall adverse event profile was similar for the fourth and fifth years of consecutive Prolia treatment. Treatment showed robust BMD gains after five continuous years (13.7 percent for lumbar spine BMD and 7.0 percent for total hip BMD). The open-label extension of FREEDOM is evaluating the long-term (up to 10 years) efficacy and safety of Prolia in 4,550 postmenopausal women. Seventy percent of eligible women from the FREEDOM study continued enrollment in the extension study; 2,343 women continued to receive Prolia treatment, and 2,207 transitioned from placebo to Prolia. Marketing of Prolia is shared by Amgen with GSK in Europe with Amgen solely in the USA and Canada and Daiichi Sankyo in Japan