TUESDAY, April 9, 2019 (HealthDay News) -- Evenity (romosozumab) injection has been approved by the U.S. Food and Drug Administration to treat osteoporosis in postmenopausal women at high risk of breaking a bone, the agency said Tuesday in a news release.
More than 10 million people in the U.S. have osteoporosis, making their thinning bones more likely to fracture, the FDA said. Most are women who have gone through menopause.
"Today's approval provides women with postmenopausal osteoporosis who are at high risk of fracture with a new treatment that will reduce this risk," said Dr. Hylton Joffe, director of the agency's Division of Bone, Reproductive and Urologic Products. "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."
Evenity is a monoclonal antibody that blocks the protein sclerostin and helps boost new bone formation. The drug's effectiveness drops after 12 doses, so no one should be given more than that amount, the FDA warned.
Evenity was evaluated in clinical trials involving more than 11,000 women with postmenopausal osteoporosis. The drug increased users' risk of cardiovascular death, heart attack and stroke, prompting the agency to require a boxed warning on the drug's label. Doctors should discontinue Evenity in any woman who has a heart attack or stroke during treatment, the FDA advised.
The most common side effects of Evenity included joint pain and headache.
The drug is produced by Amgen, based in Thousand Oaks, Calif.
Learn more about this approval.