Amgen Asks FDA to Expand Prolia’s Approval to Include an Additional Osteoporosis Condition

Amgen Asks FDA to Expand Prolia’s Approval to Include an Additional Osteoporosis Condition
Amgen has asked the U.S. Food and Drug Administration to expand its approval of the bone-building therapy Prolia (denosumab) to include an additional osteoporosis condition. The initial authorization covered men with metastatic prostate cancer who are at high risk of a fracture from the androgen deprivation therapy used to treat their disease. It also covered two osteoporosis conditions. Amgen has submitted a supplemental biologics license application that asks the FDA to approve Prolia for glucocorticoid-induced osteoporosis, or GIOP. One of the previous osteoporosis authorizations was for men with fragile bones who are at high risk of having a fracture. The other was for patients who were unable to tolerate other osteoporosis therapies or failed to respond to them. The glucocorticoid medications that doctors prescribe for many inflammatory diseases can cause osteoporosis. Evidence suggests that the risk of a fracture increases by up to 75 percent in the first three months of glucocorticoid treatment. Bone mineral density not only declines during those months but continues dropping afterward, researchers have found. "Glucocorticoid-induced osteoporosis can lead to weakened bones and debilitating fractures,” Dr. Sean E. Harper, an executive vice president at Amgen, said in a press release. "With this submission and future approval, we look forward to bringing the benefits of Prolia to patients living with this often
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