Amgen reported that it received a positive opinion in the EU for Prolia (denosumab) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, as well as for the treatment of bone loss in men with prostate cancer at increased risk of fractures.

The opinion, issued by the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP), was based on data from six Phase 3 trials. Amgen stated that "all six studies showed Prolia's ability to increase bone mineral density at all skeletal sites measured."

GlaxoSmithKline entered into a deal with Amgen in July to collaborate on the marketing of Prolia in Europe for the postmenopausal osteoporosis indication. GlaxoSmithKline's head of European pharmaceuticals, Eddie Gray, has indicated that the drugmaker is aiming to launch Prolia in Europe by mid-2010, if approved.

Reference Articles

Amgen receives CHMP positive opinion for Prolia (denosumab) in the European Union - (Amgen)

Amgen's Prolia moves closer to European approval - (BusinessWeek)

Committee for Medicinal Products for Human Use summary of positive opinion for Prolia - (EMA)

European panel recommends Amgen, Glaxo bone drug - (Forexpros)

Amgen gets positive opinion in EU for Prolia - (MarketWatch)