|Amgen, Inc. Receives Positive Opinion For Human Use For XGEVA (Denosumab) In European Union|
|By Staff and Wire Reports|
|Friday, 20 May 2011 21:05|
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended a positive opinion for the marketing authorization of XGEVA (denosumab) for the prevention of skeletal-related events in adults with bone metastases from solid tumors, revealed by Amgen, Inc. (NASDAQ:AMGN). The CHMP positive opinion is based on three pivotal, Phase 3 head-to-head trials that evaluated the effectiveness of XGEVA versus Zometa (zoledronic acid) at delaying SREs.
The CHMP also recommended to grant XGEVA an additional year of data and market exclusivity in the EU since the indication was considered significantly new for XGEVA, and based on the significant clinical benefit of the product in comparison with existing therapies.
If approved by the European Commission, Amgen would receive marketing authorization for XGEVA in all European Union Member States.
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