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XGEVAŽ (Denosumab) Granted Marketing Authorization in the European Union

Amgen (NASDAQ: AMGN) announced that the European Commission (EC) has granted marketing authorization for XGEVAŽ (denosumab) for the prevention of skeletal-related events (SREs). This approval of XGEVA applies to all 27 European Union (EU) member states. The EC also granted XGEVA an additional year of data and market exclusivity in the EU since the indication was considered new for denosumab and based on the significant clinical benefit of XGEVA in comparison with existing therapies. The marketing authorization for XGEVA is based on three pivotal, Phase 3 head-to-head trials that evaluated the effectiveness of XGEVA versus zoledronic acid at delaying SREs. The SRE clinical program for XGEVA spanned more than 50 tumor types in over 5,700 patients.

XGEVA is a fully human monoclonal antibody that binds to RANK Ligand, a protein essential for the formation, function and survival of osteoclasts (the cells that break down bone). XGEVA prevents RANK Ligand from activating its receptor, RANK, on the surface of osteoclasts, thereby decreasing bone destruction.

XGEVA is delivered as an every four week 120 mg subcutaneous injection and is not associated with renal toxicity or acute phase reactions.

Amgen has also submitted marketing applications for XGEVA in Australia, Mexico, Russia and Switzerland. In Japan, Amgen is working with its licensing partner, Daiichi-Sankyo Company, Limited and a marketing application was submitted in August 2010. In addition, Amgen and GlaxoSmithKline (GSK) have a collaboration agreement for the commercialization of XGEVA in a number of countries where Amgen does not currently have a commercial presence. In these countries, marketing applications are filed by GSK.




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