EU approvals for Amgen's osteo drug Prolia and CSL Behring HAE agent Berinert

US biotechnology major Amgen got its first ever approval for Prolia (denosumab) from the European Commission, which granted marketing authorization for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.

As a result, Prolia has been approved in all 27 European Union member states plus Norway, Iceland and Liechtenstein. The drug, which has been slated for peak annual sales of $5 billion and is viewed as Amgen's most important growth driver, is currently under 'fast track' review at the US Food and Drug Administration, with a decision from the agency expected late July. In Europe, the drug is subject to a commercialization agreement with GlaxoSmithKline, signed last year, for which the UK drug giant paid an upfront $120 million.

"The European approval of Prolia is a significant medical advance for patients with bone loss conditions," said Will Dere, senior vice president and international chief medical officer at Amgen. "In particular, we believe that Prolia will offer patients with postmenopausal osteoporosis at increased risk for fracture an important alternative to current treatments. Prolia reduces the risk of fracture through a convenient injection given every six months. Amgen is proud to make this new treatment available to physicians and their patients."