Amgen Receives CHMP Positive Opinion for XGEVA in the European Union

Amgen AMGN today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended a positive opinion for the marketing authorization of XGEVA for the prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors. If approved by the European Commission, Amgen would receive marketing authorization for XGEVA in all European Union Member States. 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.