Amgen announced EVENITY™ (romosozumab-aqqg) is now available for shipment to wholesalers in the U.S. EVENITY was approved by the U.S. Food and Drug Administration (FDA) on April 9, 2019, for the treatment of osteoporosis in postmenopausal women at high risk for fracture.
"Osteoporosis is a silent disease that can lead to devastating consequences. Unfortunately, only 20 percent of women who have experienced a fracture receive any type of osteoporosis treatment post-fracture," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. "This is unacceptable for the millions of women who have suffered from an osteoporosis-related fracture. We need to urgently make postmenopausal osteoporosis a women's health priority."
Osteoporosis is a serious, chronic condition with no cure. According to the World Health Organization, osteoporosis is a major public health crisis, affecting millions of people worldwide. In the U.S. alone, 10 million Americans suffer from osteoporosis. Osteoporosis-related fractures, known as bone breaks, are common, and the disease is responsible for an estimated two million fractures per year. After her first fracture, a woman is five times more likely to suffer another fracture within a year. In fact, her fracture risk remains elevated over time if left untreated. Fractures for postmenopausal women can be life-altering events which can lead to loss of mobility. Each year, osteoporosis-related fractures account for 432,000 hospital admissions and 180,000 nursing home admissions. Given the aging population in the U.S., annual direct costs from osteoporosis are expected to reach approximately $25.3 billion by 2025.
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The approval of EVENITY in the U.S. helps address an unmet need by providing another option for postmenopausal women at high risk for fracture who need to build bone rapidly within 12 months and to reduce the risk of a first or subsequent fracture. A full course of EVENITY therapy is 12 monthly doses administered by a healthcare provider.
EVENITY has a Boxed Warning in its product label, which advises that EVENITY may increase the risk of myocardial infarction (heart attack), stroke and cardiovascular death. EVENITY should not be initiated in patients who have had a heart attack or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. If a patient experiences a heart attack or stroke during therapy, EVENITY should be discontinued.
The most common adverse reactions (≥ 5 percent) reported with EVENITY were arthralgia (joint pain) and headache.
"There are many patients that I see in clinical practice who make lasting impressions on me. One of those patients is Judy, and while her case may seem like an extreme example, I see far too many women who have similar stories," said Andrea Singer, M.D., internist and bone health specialist at MedStar Georgetown University Hospital in Washington, D.C., and Chief Medical Officer at the National Osteoporosis Foundation. "With the approval of EVENITY, we have a new treatment option in our tool chest to find the appropriate treatment for each individual based on her clinical risk factors, goals of treatment and individual preferences."
EVENITY is a bone-building humanized monoclonal antibody. It is designed to work by inhibiting the activity of sclerostin, which simultaneously results in increased bone formation and to a lesser extent decreased bone resorption. The EVENITY development program includes 19 clinical studies that enrolled more than 14,000 patients. EVENITY has been studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program that included two large fracture trials comparing EVENITY to either placebo or active comparator in nearly 12,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing EVENITY.