New Osteoporosis Therapy for Postmenopausal Women Granted FDA Approval – APhA submits compounding comments to FDA. – (866) 348-2889.
Officials with the FDA have approved romosozumab-aqqg (Evenity, Amgen) for the treatment of osteoporosis in postmenopausal women at high risk of fracture, according to a press release. Romosozumab-aqqg is indicated for patients with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies.
By blocking the effects of the protein sclerostin, romosozumab-aqqg works to decrease the risk of fracture by increasing new bone formation. With this approval, romosozumab-aqqg is the first and only bone builder with the dual effect of increasing bone formation and to a lesser extent reducing bone resorption, according to Amgen.