Keyword: Evenity (romosozumab)
Unlike widely used bisphosphonate drugs, which only prevent the loss of bone mass, Evenity is designed to stimulate bone growth to repair damage.
Officials knocked back the filing after phase 3 data linked the sclerostin-targeting antibody to an increased risk of cardiovascular adverse events.
Amgen and UCB's romosozumab trounced a comparator drug in a trial in osteoporosis, but there's a big catch: The therapy seems to cause side effects that will delay and could scupper its chances of reaching the market.
Radius Health ($RDUS) has posted new results from its late-stage trial in women with osteoporosis as it looks to shore up its data ahead of an expected U.S. approval next spring.