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# FDA Approves Evenity for Osteoporosis
- URL: https://www.fdaweb.com/fda-approves-evenity-for-osteoporosis/
- Published: 2019-04-09T12:00:00.000Z
- Updated: 2026-09-15T01:19:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143825

FDA has approved Amgen/UBS’ Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of fracture. An agency [statement](https://www.prnewswire.com/news-releases/statement-by-douglas-throckmorton-md-deputy-center-director-for-regulatory-programs-in-fdas-center-for-drug-evaluation-and-research-on-new-opioid-analgesic-labeling-changes-to-give-providers-better-information-for-how-to-pro-300828292.html?ref=fdaweb.com) says these are women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies.

The drug’s safety and efficacy were demonstrated in two clinical trials involving a total of more than 11,000 women with postmenopausal osteoporosis. In one trial Evenity lowered the risk of a new vertebral fracture by 73% compared to placebo, while in the second trial one year of Evenity followed by one year of alendronate (Fosamax) reduced the risk of a new vertebral fracture by 50% compared to two years of Fosamax alone.

Evenity reportedly increased the risk of cardiovascular death, heart attack, and stroke in the Fosamax trial, but not in the placebo trial. It contains a Boxed Warning 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.