- The FDA’s approval is based on two P-III FRAME & ARCH studies result assessing Evenity (210mg) vs PBO & alendronate (70mg) in 7,180 & 4,093 postmenopausal women with osteoporosis respectively
- The P-III FRAME & ARCH study results: @12mos. and 24mos. significant reduction in vertebral (spine) fracture; @33 mos. reduction in risk of clinical fracture; increment in bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck @12mos.
- Evenity (romosozumab-aqqg) is a mAb, inhibits sclerostin resulting in an increment of bone formation and decreases in bone resorption and is collaboratory developed by Amgen and UCB. Evenity also has a boxed warning in its label as it increases the risk for MI, stroke, & cardiovascular death
Click here to read full press release/ article | Ref: Amgen | Image: Twitter