April 10, 2019
The U.S. Food and Drug Administration has approved a drug treatment specifically for postmenopausal women with a high risk of breaking bones.
Evenity (romosozumab) works by increasing a patient’s ability to form new bones — which is crucial for those suffering from a disease that reduces bone density and quality, the FDA said in its Tuesday announcement.
Doses are taken in two back-to-back injections administered monthly by a health care professional, according to the agency. Joint pain and headache were among side effects observed in testing, as were reactions and discomfort at the place of injection.
The FDA defined “high risk” women as those with a history of fractures, those who have multiple risk factors that could lead to fracture, or those who have tried other osteoporosis treatments without success. Evenity’s safety and efficacy was confirmed in two clinical trials enlisting more than 11,000 postmenopausal osteoporosis patients.
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According to the International Osteoporosis Foundation:
Osteoporosis, which literally means porous bone, is a disease in which the density and quality of bone are reduced. As bones become more porous and fragile, the risk of fracture is greatly increased. The loss of bone occurs silently and progressively. Often there are no symptoms until the first fracture occurs.
About one in three women and one in five men over the age of 50 worldwide are at risk of bone fracture related to osteoporosis, according to the foundation..
The FDA said the efficacy of Evenity is reduced after 12 doses, so patients should not exceed that number of doses. If further treatment is required at that point, it advises patients to begin a treatment that reduces bone breakdown.
The drug may not be for everybody who needs it.
“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,” Dr. Hylton Joffe, director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products, said in the FDA announcement.
Evenity is expected to hit the wholesale market in the United States in “about a week,” according to CNN, citing a statement from drug creator, Amgen, spokesperson Kristen Davis. At that point, the price will be release to the public.