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Amgen's Evenity Clears US FDA With Preferred Indication, Black Box Warning

 
• By Michael Cipriano

Osteoporosis treatment romosozumab-aqqg indicated for postmenopausal women at high risk for fracture; advisory committee appears to have help persuade FDA that a black box would be sufficient to manage cardiovascular risk rather than a narrower indication.

Osteoporosis upper limb bones - 3d rendering

With the US FDA's April 9 approval of Evenity (romosozumab-aqqg), Amgen Inc. appears to have gotten exactly the label it wanted.

Evenity, a first-in-class sclerostin inhibitor, is specifically labeled for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or

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