FDA Approves New Option for Postmenopausal Osteoporosis

The FDA has approved Evenity (romosozumab-aqqg) for the treatment of osteoporosis in postmenopausal women who have a high risk of fracture.

Those at high risk include women with a history of osteoporotic fracture or those with multiple risk factors for fracture, as well as women who did not respond to or are intolerant to osteoporosis therapies.

The monoclonal antibody works by blocking the effects of sclerostin and increasing new bone formation and is given in the form of 2 injections—one after another—once a month. If treatment is still needed following 12 doses of Evenity, an osteoporosis treatment that reduces bone breakdown should be started.

The safety and efficacy of the treatment were evaluated in 2 clinical trials involving more than 11,000 women with postmenopausal osteoporosis. In the first, a year of treatment with Evenity lowered the risk of new fracture in the spine by 73% compared with placebo. This benefit was maintained during the second year, when treatment with Evenity was followed by treatment with denosumab.

In the second trial, a year of treatment with Evenity followed by a year of alendronate reduced the risk of vertebral fracture by 50% compared with 2 years of alendronate alone.

Evenity contains a boxed warning stating that it may increase the risk of heart attack, stroke and cardiovascular death and should not be used in patients who have had a heart attack or stroke within the previous year.

Common adverse effects included joint pain and headache.

—Michael Potts

Reference:

FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture [press release]. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635653.htm.