Amgen Inc. (AMGN) said Thursday the U.S. Food and Drug Administration has approved Prolia as a new treatment to increase bone mass in men with osteoporosis at high risk for fracture, after patients reported greater gains at the lumbar spine in a late-stage trial.
Prolia, the first FDA-approved RANK Ligand inhibitor, is a subcutaneous injection administered by a health care professional every six months.
Prolia was approved in the U.S. in June 2010 for the treatment of postmenopausal women with osteoporosis at high risk for fracture. A few months later, the drug was approved in the U.S. as Xgeva for the prevention of skeleton-related events in patients with bone metastases from solid tumors. In the second quarter, Amgen's sales of Prolia grew three-fold to $120 million, compared to last year.
Though women usually are vulnerable to osteoporosis, the incidence among men has recently been recognized as an important public health issue. As their life span increases, more men run the risk of suffering from osteoporosis, and along with it, the chances of fracture gains traction. According to the National Osteoporosis Foundation, two million men in the U.S. have osteoporosis and another 12 million are at risk.
The new indication for Prolia is based on results from the ADAMO trial3 - a randomized, double-blind, placebo-controlled study in men with low bone mineral density, or BMD.
The study showed treatment with Prolia resulted in significantly greater gains at the lumbar spine when compared to placebo. Results also show Prolia-treated patients with bone mineral density increases at all other skeletal sites. The most common adverse reactions were back pain, arthralgia and nasopharyngitis.
Amgen closed Thursday at $82.30, up 0.72%, on a volume of about 3.7 million shares.
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