FDA Approves New Treatment for Postmenopausal Women With Osteoporosis

April 10, 2019

FDA has approved a monoclonal antibody to treat postmenopausal women who have a higher risk of bone fracture.

Postmenopausal women with osteoporosis who have a higher risk of bone fracture, either because they have a history of osteoporotic fracture, have multiple risk factors for fracture, or have failed or are intolerant of other osteoporosis therapies, can now be treated with romosozumab-aqqg (Evenity, Amgen).

FDA approved the drug, a monoclonal antibody, which blocks the protein sclerostin, allowing the romosozumab-aqqg to increase bone formation and reduce bone resorption. One dose of the treatment consists of 2 injections given one after the other once a month by a healthcare professional.

Although 50% of women older than 50 years will experience an osteoporotic fracture, only 20% of women will receive osteoporosis treatment in the year after they experience a fracture, according to the National Osteoporosis Foundation and the International Osteoporosis Foundation.

In January, the FDA Bone, Reproductive and Urologic Drugs Advisory Committee showed strong support for the drug, with 18 of the 19 members voting that it should be approved.

“A fracture due to osteoporosis can be devastating to the lives of patients,” David M. Reese, MD, executive vice president of research and development at Amgen, said in a statement in at the time. “After an osteoporotic fracture, a woman is five times more likely to suffer another fracture within the first year, and her risk remains elevated over time if untreated. Despite available therapies, these women who are at high risk for fracture could benefit from an additional treatment option that has the potential to both build new bone and slow existing bone loss.”

In 2 clinical trials with more than 11,000 women with postmenopausal osteoporosis, romosozumab-aqqg reduced the risk of a new fracture. One trial showed that a year of treatment lowered the risk of a new vertebral fracture by 73% compared with placebo, a benefit that was maintained over a second year of the trial, during which time all patients were treated with denosumab. In the second trial, the risk of a new vertebral fracture was reduced by 50% for patients treated with a year of romosozumab-aqqg followed by a year of alendronate compared with patients who received 2 years of alendronate alone.

However, compared with alendronate, romosozumab-aqqg did increase the risk of cardiovascular death, heart attack, and stroke. There was no increase in the placebo trial. As a result, the drug has a boxed warning and is contraindicated in patients who have had a heart attack or stroke in the previous year.

“Today’s approval provides women with postmenopausal osteoporosis who are at high risk of fracture with a new treatment that will reduce this risk,” Hylton V. Joffe, MD, MMSc, director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products, said in a statement. “But 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.”