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FDA approves drug for treatment of osteoporosis after menopause

Wednesday, April 17, 2019   (0 Comments)
Posted by: Diane Berg
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The New York Times (4/9, Kolata) reports that on April 9, the Food and Drug Administration gave its approval Evenity (romosozumab), “an osteoporosis drug that represents the first new treatment approach in nearly two decades – a strategy based on a rare gene mutation in people with bones so dense that they never break.” The drug is intended for postmenopausal women who are at high risk for a bone fracture. Nevertheless, the agency “said it was requiring the boxed warning on the drug’s label saying the drug should not be used by people who had a heart attack or stroke in the past year.”


Reuters (4/9, Mishra, Joseph) reports, “The decision comes months after an FDA panel overwhelmingly voted for the drug’s approval.” The newly approved drug belongs to a “new class” of medications “known as sclerostin inhibitors,” and “is administered with two 105 mg injections every month for a year, followed by chronic therapy with an antiresorptive drug.” 

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