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FDA Approves Amgen's Osteoporosis Drug Evenity

The U.S. Food and Drug Administration Tuesday approved Amgen Inc.'s (AMGN) Evenity for treatment of osteoporosis in postmenopausal women, who are at high risk of bone fractures.

More than 10 million people in the U.S. have osteoporosis, which is most common in women who have gone through menopause. People with osteoporosis have weakened bones that are more likely to fracture.

"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 Hylton Joffe, director of the Center for Drug Evaluation and Research's Division of Bone, Reproductive and Urologic Products.

However, Evenity increases the risk of cardiovascular death, heart attack and stroke in the alendronate trial, but not in the placebo trial. Evenity contains a boxed warning on its labeling stating that it may increase the risk of heart attack, stroke and cardiovascular death and should not be used in patients who have had a heart attack or stroke within the previous year.

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