FDA OKs Prolia for Treatment of Glucocorticoid-Induced Osteoporosis

Officials with the FDA have approved the use of denosumab (Prolia, Amgen) for the treatment of glucocorticoid-induced osteoporosis (GIOP), according to a press release.

The treatment is indicated for men and women at high risk of fracture, defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available therapies.

The approval is based on data from 12-month analysis of a 24-month phase 3 trial evaluating the safety and efficacy of denosumab. According to the findings, patients on glucocorticoid therapy who received denosumab had greater gains in bone mineral density (BMD) compared with those who received active comparator risedronate.

Denosumab 60 mg was administered subcutaneously every 6 months compared with oral risedronate 5 mg once daily in 795 patients receiving glucocorticoid treatment, greater than or equal to 7.5 mg/day oral prednisone, or equivalent, according to the study.

The study included 2 patient populations: a glucocorticoid-initiating subpopulation, and a glucocorticoid-continuing subpopulation. In the glucocorticoid-initiating subpopulation, patients received treatment for less than 3 months prior to study enrollment, and planned to continue treatment for a total of 6 months. In the glucocorticoid-continuing subpopulation, patients received treatment for greater than or equal to 3 months prior to study enrollment, and planned to continue treatment for a total of at least 6 months.

According to the data, in patients in both the glucocorticoid-continuing subpopulation and glucocorticoid-initiating subpopulation, denosumab demonstrated a significantly greater increase in lumbar spine BMD compared with risedronate at 1 year, with a treatment difference of 2.9% and 2.2%, respectively.

“Patients on long-term systemic glucocorticoid medications can experience a rapid reduction in bone mineral density within a few months of beginning treatment,” Kenneth F Saag, MD, MSc, study lead, said in a statement. “With this approval, patients who receive treatment with glucocorticoids now have a new option to help improve their bone mineral density.”

Denosumab is also indicated for the prevention of skeletal-related events in patients with multiple myeloma

who have developed bone metastases.

Read more on some of the upcoming drugs slated for review by the FDA in 2018.

Reference

FDA Approves Prolia® (Denosumab) For Glucocorticoid-Induced Osteoporosis [news release]. Amgen’s website. https://www.amgen.com/media/news-releases/2018/05/fda-approves-prolia-denosumab-for-glucocorticoidinduced-osteoporosis/. Accessed May 22, 2018.