Biopharmaceutical giant Amgen has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug Prolia (denosumab) to treat glucocorticoid-induced osteoporosis (GIOP) in patients at high risk of fractures. This approval marks a significant expansion of Prolia’s indication in China, where it is already approved to treat osteoporosis in postmenopausal women and men at high risk of fractures, both indications covered under the National Reimbursement Drug List (NRDL).
The latest approval is supported by the results of a global Phase III study in GIOP patients, which demonstrated that Prolia significantly increased lumbar spine bone mineral density (BMD) compared to the control group at 12 months. The study included patients who had been on glucocorticoids for an extended period and those who were new to glucocorticoid treatment. The efficacy of Prolia was consistent across different demographics, including gender, age, race, and menopausal status, and the drug showed a favorable safety profile.- Flcube.com
