Human therapeutics company Amgen (NASDAQ:AMGN) reported on Monday the availability of EVENITY (romosozumab-aqqg) in the US market for the treatment of osteoporosis.
The company added the US Food and Drug Administration (FDA) approved EVENITY (romosozumab-aqqg) is now available for shipment to wholesalers in the US for the treatment of osteoporosis in postmenopausal women at high risk for fracture. Osteoporosis is a serious, chronic condition with no cure and osteoporosis-related fractures, known as bone breaks, are common and the disease is responsible for an estimated two million fractures per year.
According to the company, the EVENITY is a bone-building humanized monoclonal antibody 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.
Under the EVENITY development programme, the company enrolled more than 14,000 patients in 19 clinical studies. It has been studied for its potential to reduce the risk of fractures in an extensive global Phase 3 programme that included two large fracture trials comparing EVENITY to either placebo or active comparator in nearly 12,000 postmenopausal women with osteoporosis.
Following the US FDA approval, the company will market EVENITY at a US list price of USD1,825 per dose, or USD21,900 for a full course of treatment. This list price for a full course of therapy is 34 to 74% lower than currently available anabolic agents over their full course of therapy.
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