FDA approves new indication for Amgen's Xgeva

USA-based Amgen (Nasdaq: AMGN), the world’s largest independent biotech firm, says the US Food and Drug Administration has approved a new indication for Xgeva (denosumab), for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy. Amgen’s shares gained 1.1% to $171.10 by mid-morning.

Xgeva was approved in 2010 and granted Orphan Drug designation by the FDA, which is reserved for drugs that are intended for the treatment of rare diseases affecting fewer than 200,000 people in the USA. In the third quarter of 2014, sales of Xgeva in its current indications increased 22% to $318 million.

"Our continued study of Xgeva reinforces Amgen's ongoing commitment to address the unmet needs of cancer patients," said Sean Harper, executive vice president of R&D at Amgen. "This latest FDA approval for Xgeva provides an important new therapeutic option for patients with a rare condition that cannot be resolved with bisphosphonate therapy."