Amgen gains EU approval for Xgeva; Resolves G-CSF patent dispute with Teva

18 July 2011

The European Commission has granted marketing authorization for US biotech giant Amgen’s (Nasdaq: AMGN) Xgeva (denosumab) for the prevention of skeletal-related events (SREs) (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors.

The Commission also granted Xgeva an additional year of data and market exclusivity in the European Union since the indication was considered new for denosumab and based on the significant clinical benefit of Xgeva compared with existing therapies.

Added indication could boost sales to $2.4 billion

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