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MAY 23, 2018

FDA Grants New Indication for Prolia to Treat Glucocorticoid-Induced Osteoporosis

By SPC News Staff

Deosumab (Prolia, Amgen) has received a new indication from the FDA to treat glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other osteoporosis therapy. 

The approval was based on data from a phase 3 trial that showed patients on glucocorticoid therapy who received deosumab had greater gains in bone