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Amgen's Prolia Moves Closer to European Approval

From Associated Press (December 18, 2009)

Thousand Oaks, Calif.--Amgen Inc. said Friday a European advisory committee recommended approval of the biotechnology company’s osteoporosis drug Prolia, also called denosumab.

The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of the drug as a treatment for osteoporosis in postmenopausal women. European regulators, much like the FDA, often follow the advice of their advisory committees.

The drug is still under regulatory review in the U.S. as a potential treatment for postmenopausal osteoporosis and as a treatment for bone loss in breast and prostate cancer patients undergoing therapy.

Prolia is viewed by Wall Street as Amgen’s next blockbuster drug and a way to revive the company’s revenue following declining sales of the anemia drug Aranesp. But, the FDA has asked for more data and information on the drug before considering it for approval.

Wall Street still expects the drug to gain FDA approval as a postmenopausal osteoporosis treatment in the first quarter. The FDA has requested a risk-mitigation plan for that indication.

Shares of Amgen closed at $54.58 Thursday.

Posted: December 2009