Amgen Inc. (AMGN) and UCB’s investigational drug Evenity, proposed for the treatment of osteoporosis in postmenopausal women at high risk for fracture, is all set to be reviewed by an FDA panel on January 16, 2019.Evenity was turned down by the FDA last July, with the companies being asked to submit the efficacy and safety data from an additional phase III active-comparator study, dubbed ARCH.In the ARCH study, treatment with Evenity for 12 months followed by Merck & Co.’s (MRK) Fosamax significantly reduced the incidence of new vertebral, clinical and non-vertebral fractures in postmenopausal women with osteoporosis at high risk for fracture, compared to Fosamax alone.However, the rate of cardiovascular serious adverse events was higher in patients treated with EVENITY compared to Fosamax (2.5 percent Evenity versus 1.9 percent Fosamax at 12 months), raising a concern.The companies resubmitted the Biologics License Application for Evenity to the FDA with the required data in July of this year. Before the regulatory agency takes a final decision, the Biologics License Application is slated to be reviewed by a panel of outside experts on the above-mentioned date, i.e. on January 16, 2019.AMGN closed Friday’s (Dec.21, 2018) trading at $180.21, down 2.57%.