For Immediate Release:April 09, 2019 Español The U.S. Food and Drug Administration today approved Evenity
(romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (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. More than 10 million people in the U.S. have osteoporosis, which is most common in women who have gone through menopause. People with osteoporosis have weakened bones that are more likely to fracture. “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 Hylton V. Joffe, M.D, M.M.Sc., director of the Center for Drug Evaluation and Research’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 effects of the protein sclerostin and works mainly by increasing new bone formation. One dose of Evenity consists of two injections, one immediately following the other, given once a month by a health care professional. The bone forming effect of Evenity wanes after 12 doses so more than 12 doses should not be used. If osteoporosis therapy is needed after the 12 doses, patients should begin an osteoporosis treatment that reduces bone breakdown. The safety and efficacy of Evenity were demonstrated in two clinical trials involving a total of more than 11,000 women with postmenopausal osteoporosis. In the first trial, one year of treatment with Evenity lowered the risk of a new fracture in the spine (vertebral fracture) by 73% compared to placebo. This benefit was maintained over the second year of the trial when Evenity was followed by one year of denosumab (another osteoporosis therapy) compared to placebo followed by denosumab. In the second trial, one year of treatment with Evenity followed by one year of alendronate (another osteoporosis therapy) reduced the risk of a new vertebral fracture by 50% compared to two years of alendronate alone. Evenity followed by alendronate also reduced the risk of fractures in other bones (nonvertebral fractures) compared to alendronate alone. Evenity increased the risk of cardiovascular death, heart attack and stroke in the alendronate trial, but not in the placebo trial. Therefore, Evenity contains a boxed warning on its labeling stating that it may increase the risk of heart attack, stroke and cardiovascular death and should not be used in patients who have had a heart attack or stroke within the previous year. Health care professionals should also consider whether the benefits of Evenity outweigh its risks in those with other risk factors for heart disease and should discontinue Evenity in any patient who experiences a heart attack or stroke during treatment. Common side effects of Evenity included joint pain and headache. Injection site reactions were also observed. The FDA granted the approval of Evenity to Amgen. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. Related Information### InquiriesThousands of people are set to benefit from the first new treatment for osteoporosis for over a decade  Over 20,000 people with severe osteoporosis who are at high risk of fracture could be eligible for a new treatment—romosozumab—which helps to form bone and increase existing bone strength. Osteoporosis leads to nearly 9 million fractures around the world each year, and over 300,000 people per year attend hospitals in the UK with fractures caused by osteoporosis. Current treatments for people with severe osteoporosis after menopause include bisphosphonates, such as alendronic acid, and other types of medicines, such as denosumab or teriparatide. A clinical trial showed that people who took romosozumab before alendronic acid had a 50% lower relative risk of vertebral fractures over 24 months than people having alendronic acid alone. Analysis also showed that the risk of non-vertebral fractures was 19% lower for people who had romosozumab before alendronic acid, compared with those having alendronic acid alone. ‘Clinically significant results’Helen Knight, acting director for medicines evaluation at NICE, said: ‘People with severe osteoporosis often have a poorer quality of life. Fractures due to osteoporosis can lead to hospital stays and limit people’s mobility and independence. Romosozumab has shown clinically significant results that could have a huge impact on the lives of people who have severe osteoporosis. ‘Romosozumab is the only drug available that can help to form bone as well as increase existing bone strength. It is the first new treatment for osteoporosis for several years and I’m delighted we have been able to recommend this drug as an option for people with severe osteoporosis.’ Credit: Lead image: Kateryna_Kon/stock.adobe.com Image 1: Kateryna_Kon/stock.adobe.com Is there a safer alternative to Fosamax?Here are a few alternatives that may be options for you. There are several other bisphosphonates available, including zoledronic acid (Reclast) and risedronate (Actonel). Unlike the other bisphosphonates, Reclast is given intravenously and is not available as an oral pill.
What is the newest treatment for osteoporosis?Romosozumab (Evenity).
This is the newest bone-building medication to treat osteoporosis. It is given as an injection every month at your doctor's office and is limited to one year of treatment.
Is Evenity worth the risk?Evenity can increase your risk for heart attack and stroke. It can also increase your risk for death due to a cardiovascular (heart or blood vessel) problem. In fact, Evenity has a boxed warning for these side effects. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).
Are osteoporosis medications worth the risk?The Society's Clinical Practice Guideline on osteoporosis treatment in postmenopausal women state that the benefits of bone-directed medications outweigh their risk for women at high risk of breaking a bone, especially those who recently experienced a fracture.
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