Amgen Inc. won U.S. approval to expand marketing of its bone-strengthening drug Prolia for people using hormone therapy to treat prostate and breast cancer.
The Food and Drug Administration cleared the drug, also known as denosumab, to reduce fracture risks in breast cancer patients taking drugs that halt estrogen production and prostate cancer patients treated with androgen-deprivation therapies, Thousand Oaks, California-based Amgen said today in a statement.
Amgen, the world’s biggest biotechnology company, is counting on denosumab to boost growth amid slowing sales of the anemia drugs Aranesp and Epogen, its core products. The drug won FDA approval last year as a treatment for osteoporosis in postmenopausal women. Sales of the drug may reach $1.17 billion in 2014, according to the average estimate of four analysts surveyed by Bloomberg.
“Bone loss and fractures are recognized adverse effects of hormone ablation therapies but we have not had an approved treatment option to prevent these problems for our patients,” Matthew Smith, director of the Genitourinary Malignancies Program at Massachusetts General Hospital Cancer Center in Boston, said in the company’s statement.
Amgen declined 18 cents, or less than 1 percent, to $56.53 at 4 p.m. New York time in Nasdaq Stock Market trading.