Fifth added FDA indication for Prolia

The US Food and Drug Administration has approved the use of Prolia(denosumab) for the treatment of glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy, according to the drug’s manufacturer, US biotech major Amgen (Nasdaq: AMGN).

This approval, which is now the fifth from the FDA Prolia, which generated revenues of $494 million in the first quarter of this year, is based on data from a Phase III study which showed patients on glucocorticoid therapy who received Prolia had greater gains in bone mineral density (BMD) compared to those who received active comparator (risedronate).

"As a leader in bone health with more than 20 years of osteoporosis research experience, we are pleased that Prolia will now be available for patients at high risk of fracture who are suffering from bone loss due to long-term glucocorticoid treatment," said Sean Harper, executive vice president of R&D at Amgen."This is a serious condition that leads to rapid decreases in bone mineral density and increased risk of fracture. This approval gives patients and physicians a new treatment option," he noted.