Amgen Inc. said the European Commission approved its Prolia treatment for patients with a certain type of bone-loss disease.
The Thousand Oaks, Calif.-based biotechnology giant said the European regulator approved Prolia, or denosumab, for treating glucocorticoid-induced osteoporosis in adult patients at increased risk of fracture.
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, a steroid hormone used to treat diseases such as inflammatory arthritis. Long-term glucocorticoid therapy is likely to cause a rapid and early decline in the density of bone mineral and an increase in the risk of fracture.
Amgen said the approval was based on data from a phase 3 study in which Prolia demonstrated a greater increase in lumbar spine bone mass density versus risedronate at one year and two years.
In April, the European Medicines Agency recommended Prolia to treat bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. Amgen said Prolia is now approved for three uses in Europe.
The U.S. Food and Drug Administration approved the expanded use of Prolia in May for treating osteoporosis associated with newly initiating or sustained systemic glucocorticoid therapy in men and women at high risk of fracture.
