BioCentury
ARTICLE | Clinical News

Amgen, UCB pass second Phase III osteoporosis test

February 23, 2016 2:39 AM UTC

Amgen Inc. (NASDAQ:AMGN) and partner UCB Group (Euronext:UCB) said romosozumab ( AMG 785) met the co-primary endpoints of significantly reducing the incidence of new vertebral fracture through months 12 and 24 in the 7,180-patient Phase III FRAME trial to treat osteoporosis in postmenopausal women. The data for the humanized mAb against sclerostin were among the two clinical events that buysiders told BioCentury could drive Amgen's growth in 2016 (see BioCentury, Jan. 11).

In the double-blind portion of the trial, monthly subcutaneous injections of 210 mg romosozumab led to a significant, 73% reduction in the relative risk of a vertebral fracture at 12 months vs. placebo (p-value undisclosed). ...