/p>The US Food and Drug Administration (FDA) has approved event (romosozumab), drug developed by pharmaceutical companies UCB and Amgen for him treatment of osteoporosis in postmenopausal women at high risk of fracture.
Evenity is a humanized monoclonal antibody for bone development designed to inhibit the activity of sclerostin that has been studied in several large clinical trials involving more than 14,000 patients. It is the first and only dual effect bone former: on the one hand, it increases bone formation and, on the other, although to a lesser extent, it reduces bone resorption (or bone loss), which translates into a decreased risk of fracture.
Treatment with this new drug involves a subcutaneous dose per month for a year, and since osteoporosis is a chronic pathology, treatment with an antiresorptive agent should be considered once romosozumab treatment is completed, these pharmaceutical companies indicate.
As indicated by the Dr. Pascale RichettaHead of Bone Health and Executive Vice President of , “Women who suffer a fracture due to osteoporosis have a significant risk of sustaining a second fracture within one to two years; However, many patients do not have a diagnosis of osteoporosis as the underlying cause of the fracture, which is why they do not always receive adequate care and, consequently, may suffer new fractures”.
In this sense, the Dr. Felicia Cosman, Professor of Medicine at Columbia University College of Physicians and Surgeons; magazine co-editor Osteoporosis International and principal investigator of the FRAME clinical study, highlights that “After 30 years caring for women with osteoporosis and conducting clinical research, I know that women at high risk of fracture need other treatment than rquickly reduce the chance of fracturing«.
“Romosozumab acts with a novel mechanism of action that reduces the risk of new vertebral fractures within 12 months and produces significant and rapid improvements in bone mass. These benefits are sustained with the transition to an antiresorptive medication and address a critical need for patients at high risk of fracture”says this specialist.
He Dr. David M. ReeseExecutive Vice President of Research and Development at highlighted that “one in two women will suffer a fracture in her lifetime due to osteoporosis. These fractures can be devastating, with many ending in hospitalizations and life-changing consequences. The FDA approval of romosozumab represents an important therapeutic development for patients who need a drug that canrapidly increase bone mineral density and help reduce the risk of future fractures within 12 months. Postmenopausal osteoporosis is a significant and often overlooked health problem for women.”.
The osteoporosis is a serious chronic disease that has no cure. According to the data handled by the World Health Organization (WHO), this pathology constitutes a major public health crisis It affects millions of people around the world. Fractures related to osteoporosis, called fragility fractures, are very common: approximately two million fractures each year. And it must be taken into account that, after the first fracture, a woman is five times more likely to suffer another one during that year. In fact, if the underlying osteoporosis is not treated, the increased risk of suffering a second fracture remains over time.