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# Amgen sBLA for Prolia in Expanded Osteoporosis Use
- URL: https://www.fdaweb.com/amgen-sbla-for-prolia-in-expanded-osteoporosis-use/
- Published: 2017-07-31T12:00:00.000Z
- Updated: 2026-09-14T22:37:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139255

Amgen has submitted a supplemental BLA for Prolia (denosumab) for treating patients with glucocorticoid-induced osteoporosis. The submission is based on a Phase 3 study evaluating the safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid treatment. The data showed that treatment with Prolia for 12 months led to statistically significant greater gains in bone mineral density at the lumbar spine and total hip compared to risedronate, both in patients on sustained glucocorticoid therapy and in those newly initiating glucocorticoid therapy, the company says. Adverse events and serious adverse events were similar across treatment groups and consistent with the known safety profile of Prolia, it says.

Prolia is currently indicated for treating postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. it is also indicated for increasing bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.