The U.S. Food and Drug Administration recently approved a new treatment to combat osteoporosis in high-risk postmenopausal women. Osteoporosis is a disease that weakens bones, making them more susceptible to breaks. The National Osteoporosis Foundation estimates that 50% of women and 25% of men will break a bone in their lifetime due to osteoporosis. In the FDA’s release about the new drug Elizabeth Thompson, the CEO of the National Osteoporosis Foundation, estimated that “80 percent of patients who have had one or more osteoporotic-related fractures are not being identified or treated."
For women, osteoporosis is a higher risk than heart attack, stroke, and breast cancer combined. Post-menopausal women are at a higher risk for osteoporosis due to reductions in estrogen production, which among other things helps to protect bone density. The Office on Women’s Health estimates that women may lose up to 25% of bone mass in the first ten years after menopause.
The drug—romosozumab, branded as Evenity—was co-developed by biopharmaceutical companies Amgen and UCB, based in the United States and Belgium, respectively. Evenity is a bone-building treatment that will both increase bone formation and reduce bone loss to reduce the risk of fracture. Technically speaking, it is a bone-building humanized monoclonal antibody that works by inhibiting the activity of sclerostin to achieve the desired results. Development of Evenity included 19 clinical studies with more than 14,000 patients since 2004, two of which focused solely on post-menopausal women.
In the FDA’s announcement the executive vice president of Research and Development at Amgen, Dr. David Reese stated that “the FDA approval of Evenity represents an important therapeutic development for patients who need a medicine that can rapidly increase bone mineral density and reduce the risk of future fractures within 12 months.”
Side effects of Evenity include the increased risk of heart attack, stroke, and cardiovascular death. Because of these risks, Amgen officials caution that patients should be selected very carefully to ensure that the benefits of the drug outweigh the risks.
The treatment must be administered by a healthcare professional and consists of 12 injections. If further osteoporosis treatment is necessary after 12 months, a different type of treatment should be used. Evenity is expected to be available in the United States this month.