FDA approves osteoporosis drug

Boosting Bone Formation

The US Food and Drug Administration (FDA) has approved Evenity, or romosozumab, a new treatment for osteoporosis in postmenopausal women who are at high risk of bone fractures. According to a story reported by Jacqueline Howard of CNN, the drug -- which works primarily by boosting bone formation -- is approved to treat osteoporosis in women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have not responded to other types of osteoporosis therapies.

Dr. Hylton V. Joffe, director of the FDA Center for Drug Evaluation and Research's Division of Bone, Reproductive and Urologic Products, said that the approval “provides women with postmenopausal osteoporosis who are at high risk of fracture with a new treatment that will reduce this risk." He cautioned, "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."

Evenity was developed by Amgen and UCB, two pharmaceutical companies that began collaborating on development in 2004. It is anticipated that the drug will be available from select wholesalers in the United States for physicians to order sometime in April. At that time the price will be made publicly available, according to Amgen.

The FDA explained that one dose of Evenity is given as two back-to-back injections once per month by a health care professional. The agency said that no more than 12 doses should be used on a patient. If that patient still requires treatment for osteoporosis after 12 months, she should seek other types of medication.

Dr. David M. Reese, executive vice president of research and development at Amgen, said, "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. Postmenopausal osteoporosis is a significant women's health issue that far too often gets overlooked. Amgen is committed to combatting this disease to help women at high risk for fracture reduce their risk of a first and subsequent fracture."

The FDA related that the safety and efficacy of Evenity were tested in two clinical trials involving more than 11,000 women with postmenopausal osteoporosis. While the trials discerned that the drug was effective in reducing the risk of a new fracture, the FDA stated that there were some side effects, including an increased risk of cardiovascular death, heart attack and stroke.

The drug packaging has a "boxed warning" listing those risks and saying that the drug should not be used in patients who have suffered a heart attack or stroke during the previous year. Other side effects of Evenity are listed as joint pain and headache, and possible reactions or discomfort at the injection sites.

Osteoporosis, a disease involving low bone mass and deterioration of bone tissue, leads to a heightened risk of bone fractures, including those of the hip, spine and wrist. Of the estimated 10 million people in the United States with osteoporosis, it is estimated that more than 80 percent are women.

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