US regulators have approved a new indication for Amgen’s Prolia, allowing its use to treat glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture.
The decision allows physicians to prescribe the drug to patients with a history of osteoporotic fracture, those with multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
The approval is based on Phase III data showing that patients who received Prolia (denosumab) had greater gains in bone mineral density (BMD) compared to those who received its Actonel (risedronate).
Read more: http://www.pharmatimes.com/news/fda_clears_amgens_prolia_for_glucocorticoid_osteoporosis_1236621