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Thursday, Apr 18, 2024

FDA Approves Amgen Osteoporosis Drug

The U.S. Food and Drug Administration has approved Amgen Inc.’s Evenity, an osteoporosis drug, according to a statement from the Thousand Oaks company on Tuesday. Evenity, which was created to target osteoporosis in postmenopausal women, is the first of its kind to increase bone formation and reduce bone loss at the same time, Amgen said. This osteoporosis therapy is intended to be administered for 12 months, followed by ongoing “anti-resorptive,” or anti-bone loss therapy, to reduce the risk of fractures. “Osteoporosis is a serious disease that is underdiagnosed and often goes untreated. In fact, approximately 80 percent of patients who have had one or more osteoporotic-related fractures are not being identified or treated,” said Elizabeth Thompson, chief executive of the National Osteoporosis Foundation. “This approval is great news for patients and physicians because it gives them another much needed treatment option to help reduce the risk of life changing fractures.” Evenity is expected to be available next week at select wholesalers in the U.S. – the price will be announced at this time. Shares of Amgen (AMGN) closed Wednesday up 91 cents, or 47 percent, to $193.89 on the Nasdaq.

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