Amgen's Prolia gets FDA nod for men with osteoporosis

The US Food and Drug Administration last week approved a new indication for world biotech leader Amgen’s (Nasdaq: AMGN) Prolia (denosumab) as a treatment to increase bone mass in men with osteoporosis at high risk for fracture.

Prolia, the first FDA-approved RANK ligand inhibitor, is a subcutaneous injection administered by a health care professional every six months. Prolia has been approved in the USA since June 2010 to treat postmenopausal women with osteoporosis at high risk for fracture. The drug generated sales of $120 million in the second quarter of this year, a year-on-year rise of 36%. Under the trade name Xgeva, denosumab is also approved for the prevention of skeleton-related events in patients with bone metastases from solid tumors.

"While osteoporosis and osteoporosis-related fractures are more commonly associated with postmenopausal women, osteoporosis in men is a significant issue that is increasing in prevalence as life expectancies rise," said Sean Harper, executive vice president of R&D at Amgen, adding: "Fractures can be a life-changing event, so we are pleased that we can offer a new treatment option for the growing number of men with osteoporosis at high risk for fracture."