The FDA approved romosozumab-aqqg (Evening, Amgen) to treat osteoporosis in post-maritime women who are at high risk of fracture. These include women with previous osteoporotic fracture or multiple risk factors for broken, or have failed or have intolerance with other osteoporosis therapies.
Romosozumab-aqqg is a monochrome antibody that prevents sclerostin effects and increases new bone formation. As the effect of bone formation in effect after 12 doses, additional doses should not be used. If there is a need for additional osteoporosis therapy, patients should begin a treatment that reduces bone dissolution.
Romosozumab-aqqg safety and efficacy was demonstrated in two clinical trials involving over 11,000 women with post-menopausal osteoporosis. In the first trial, one year of treatment with romosozumab-aqqg reduced the risk of new 73% vertebrate fractures compared to placebo.
In the second trial, one year of treatment with romosozumab-aqqg and one year of alendronate subsequently reduced the new vertebrate broken risk by 50% compared to two-year alendronate. Also, the risk of romosozumab-aqqg is a risk of non-vertebral alendronate broken risk compared to alendronate only.
Romosozumab-aqqg increased the risk of cardiovascular death, heart attack, and stroke in the alendronate trial, but not in the placebo trial. A drug warning about the possible increase in risk of heart attack, stroke, and cardiovascular death, should not be used in patients with a heart attack or stroke in the previous year.
Source: FDA, April 9, 2019