Amgen Inc. said the U.S. Food and Drug Administration approved its medicine Prolia to treat patients with a certain type of bone loss disease.
The U.S. regulator approved Prolia, or denosumab, for treating glucocorticoid-induced osteoporosis 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.
Osteoporosis is a bone disease that occurs when the body loses too much bone, makes too little bone or both. Glucocorticoids are a class of corticosteroids, which are a class of steroid hormones used to treat diseases such as inflammatory arthritis.
The Thousand Oaks, Calif.-based company said the approval was based on data from a phase 3 study, which showed patients on glucocorticoid therapy who received Prolia had greater gains in bone mineral density compared to those who received risedronate.
Prolia is approved in the U.S. to treat postmenopausal women with osteoporosis at high risk for fracture or patients in whom prior therapy has failed.
In April, the European Medicines Agency approved Prolia to treat bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.