Many aging Americans face the risk of fractures due to osteoporosis. Now, they have a new means of fighting back, thanks to the U.S. Food and Drug Administration’s approval of a new treatment on Tuesday.
The FDA gave its OK to Evenity, an injected therapy developed by drug giant Amgen. Evenity (romosozumab) is a type of therapy known as a monoclonal antibody, and it helps build new bone by blocking the effect of a protein called sclerostin, the agency explained.
Evenity’s approval was limited, however: It’s only meant for use against osteoporosis in women at a high risk of 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,” the FDA said in a news release.
The move to restrict use is needed, the FDA said, because the new drug does come with risks.
“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,” said the FDA’s Dr. Hylton Joffe. He directs the FDA’s Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products.
A special boxed warning will outline Evenity’s heart risks on its labeling, the FDA said. Other common side effects include joint pain and headache.
A dose of Evenity requires two injections, one immediately following the other, given once a month by a health care professional. And the bone-forming effects of the treatment “wanes after 12 doses, so more than 12 doses should not be used,” the FDA said.
Still, the therapy does seem effective for some women. In one trial of over 11,000 postmenopausal women with osteoporosis, a year of Evenity cut their odds for a spinal fracture by 73% compared to placebo, the FDA noted, and the benefit appeared to continue over two years.
In a second trial, taking Evenity for a year, then following that with a year of an older drug, alendronate (Fosamax) cut the risk of a new vertebral fracture in half, compared to two years of alendronate alone, the FDA said.
More than 10 million people in the United States have osteoporosis, with most cases occurring in postmenopausal women.