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CHMP backs Prolia, Menveo, Revolade

December 19, 2009 1:31 AM UTC

EMEA's CHMP issued several positive opinions on Friday, including a recommendation for Prolia denosumab from Amgen Inc. (NASDAQ:AMGN) to treat osteoporosis in postmenopausal women at increased risk of fractures and to treat bone loss in men undergoing hormone ablation for prostate cancer at increased risk of fractures. In October, FDA issued complete response letters for Prolia to treat and prevent osteoporosis and to treat and prevent bone loss due to hormone ablation therapy in breast and prostate cancer patients. Amgen was up $1.22 to $55.80 on Friday.

The committee also backed Menveo, a meningococcal vaccine from Novartis AG (NYSE:NVS; SIX:NOVN); and Revolade ( Promacta - U.S.) eltrombopag from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat chronic idiopathic thrombocytopenic purpura (ITP). GSK has rights to eltrombopag from Ligand Pharmaceuticals Inc. (NASDAQ:LGND), which was up $0.09 to $1.92. ...