Bone drug from Amgen and Glaxo wins EU approval

Amgen's keenly awaited new drug Prolia, or denosumab, has been approved in Europe as a treatment for the brittle bone disease osteoporosis, the US biotech giant said on Friday. The green light from the European Commission - which had been expected following a positive recommendation by the European Medicines Agency in December - marks the first approval of the product worldwide. GlaxoSmithKline will help commercialise the medicine in Europe, throwing its marketing weight behind a product that industry analysts expect to make billions of dollars in annual sales. Prolia is administered every six months as an under-the-skin injection and is the first in a new class of drugs designed to inhibit proteins that activate bone-destroying cells. In its initial indication it will be given to women with post-menopausal osteoporosis and men with prostate cancer who, as a result of hormone therapy, are at increased risk of bone fractures. In the United States, the Food and Drug Administration is due to decide by late July whether to approve Prolia in osteoporosis. The drug is widely considered to be Amgen's most important future growth driver. It is also being developed for wider use in cancer patients and an additional approval in this indication would translate into significantly higher sales.