The U.S. Food and Drug Administration approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture).
These are women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies.
More than 10 million people in the U.S. have osteoporosis, which is most common in women who have gone through menopause.
People with osteoporosis have weakened bones that are more likely to fracture.
Side-effects of Evenity:
Evenity may increase the risk of heart attack, stroke and cardiovascular death so it’s important to carefully select patients for this therapy, which includes avoiding use in patients who have had a heart attack or stroke within the previous year.
Mechanism dose of Evenity:
Evenity is a monoclonal antibody that blocks the effects of the protein sclerostin and works mainly by increasing new bone formation.
One dose of Evenity consists of two injections, one immediately following the other, given once a month by a health care professional.
The bone forming effect of Evenity wanes after 12 doses so more than 12 doses should not be used.
If osteoporosis therapy is needed after the 12 doses, patients should begin an osteoporosis treatment that reduces bone breakdown.
Clinical trials of Evenity:
The safety and efficacy of Evenity were demonstrated in two clinical trials involving a total of more than 11,000 women with postmenopausal osteoporosis.
In the first trial, one year of treatment with Evenity lowered the risk of a new fracture in the spine (vertebral fracture) by 73% compared to placebo. This benefit was maintained over the second year of the trial when Evenity was followed by one year of denosumab (another osteoporosis therapy) compared to placebo followed by denosumab.
In the second trial, one year of treatment with Evenity followed by one year of alendronate (another osteoporosis therapy) reduced the risk of a new vertebral fracture by 50% compared to two years of alendronate alone. Evenity followed by alendronate also reduced the risk of fractures in other bones (nonvertebral fractures) compared to alendronate alone.
The FDA granted the approval of Evenity to Amgen.