The US Food & Drug Administration (FDA) has approved a new treatment for osteoporosis in postmenopausal women presenting with a high risk of fracture or who are intolerant to or have not had success with existing therapies. The drug, EVENITY (romosozumab-aqqg; Amgen), was approved April 9 and became available for shipment to wholesalers in the US on April 15.
According to the National Osteoporosis Foundation (NOF), over 10 million people in the US have osteoporosis, with another 40+ million at risk for developing the disease. Postmenopausal women are more commonly affected than other patient demographics due to the resulting sharp decline in the bone-protecting hormone estrogen. “This disease causes an estimated 2 million broken bones each year…,” said Amy Porter, executive director and CEO of NOF. The related annual cost burden is $19 billion.
Existing therapies for this patient population—a family of drugs called bisphosphonates—prevent bone loss. EVENITY, however, is a monoclonal antibody that not only decreases bone loss, but it also increases new bone formation by blocking the protein sclerostin. Thus, fracture risk is reduced. Each dose consists of two consecutive injections administered over the course of 12 months; more than 12 doses should not be used as the effect of EVENITY diminishes.
“[This] approval provides women with postmenopausal osteoporosis who are at high risk of fracture with a new treatment that will reduce this risk,” said Hylton V. Joffe, MD, MMSc, director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products.
The treatment is not risk-free. The EVENITY drug label comes with a black box warning indicating an increased risk of heart attack, stroke, and cardiovascular death. Patients who have had a heart attack or stroke within the prior year should not take EVENITY. Patients who experience a heart attack or stroke while taking EVENITY should discontinue treatment. Common side effects include headaches and joint pain.
FDA approval of EVENITY was based on the results of two clinical trials involving a cohort of over 11,000 women with postmenopausal osteoporosis. The approval comes with a caveat. The FDA is requiring a post-marketing assessment, to include a 5-year observational feasibility study, of the cardiovascular safety of the drug in women with postmenopausal osteoporosis.