A new treatment for osteoporosis in postmenopausal women has received US Food and Drug Administration approval, CNN reports. The FDA made the announcement on Tuesday regarding the drug called romosozumab, under the brand name Evenity. Evenity helps improve bone mineral density, thereby reducing the risk of fracture.
The FDA said that Evenity is a viable and effective treatment method for women with a history of osteoporosis, fractures, those with multiple fracture risk factors, and those who have found other types of osteoporosis therapies ineffective.
"Today's approval provides women with postmenopausal osteoporosis who are at high risk of fracture with a new treatment that will reduce this risk," said FDA Center for Drug Evaluation and Research's Division of Bone, Reproductive, and Urologic Products director Dr. Hylton V. Joffe.
"But Evenity may increase the risk of heart attack, stroke and cardiovascular death so it's important to carefully select patients for this therapy, which includes avoiding use in patients who have had a heart attack or stroke within the previous year," he warned.
Pharmaceutical companies Amgen and UCB have collaborated on developing the drug since 2004. According to Amgen spokeswoman Kristen Davis, Evenity should be available for physicians to order from select wholesalers within the next few days, at which point the price will be made known to the public.
"The FDA approval of Evenity represents an important therapeutic development for patients who need a medicine that can rapidly increase bone mineral density and help reduce the risk of future fractures within 12 months," said Amgen executive vice president of research and development Dr. David M. Reese in a news release.