WASHINGTON (AP) – Biotech drugmaker Amgen says federal health regulators approved its bone-strengthening drug for preventing fractures and skeletal-problems in patients with advanced cancer.
The Food and Drug Administration cleared the company’s drug denosumab for patients with solid tumors. The FDA approved the drug based on three studies that showed it worked at least as well as Novartis’ Zometa in preventing bone-related complications.
Amgen already sells the drug under the name Prolia, but as a treatment for osteoporosis caused by menopause. The company will market the drug for its new use as Xgeva.
More than 50 percent of cancer patients experience complications when cancer spreads to their bones, according to the company.
Doctors will administer Xgeva to patients in once-a-month injections. The drug works by blocking a protein that breaks down bone cells.
Date: November 18, 2010
Source: Associated Press