Amgen's Prolia approved in Europe

The European Commission granted approval for Amgen's Prolia (denosumab) as a treatment for osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, the company announced. The approval is the first for the drug worldwide, according to Amgen..

The decision, which followed a positive recommendation from the European Medicines Agency in December, was based on results of six Phase III trials, including two that showed that Prolia administered every six months reduced the incidence of fractures. In all six studies, the drug increased bone mineral density at all skeletal sites measured.

Under a deal entered in July, GlaxoSmithKline will collaborate with Amgen on the marketing of the drug in Europe for the postmenopausal osteoporosis indication, as well as in Australia, New Zealand and Mexico once the product is approved in these countries. Amgen retains rights to Prolia for oncology indications in Europe and all rights in North America.

In the US, the FDA is scheduled to make a decision by late July whether to approve the drug for the treatment of osteoporosis after requesting additional information last year.

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