- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval for Amgen's (NASDAQ:AMGN) XGEVA (denosumab) for the prevention of skeletal-related events in adult patients with advanced malignancies involving bone. The specific application was the inclusion of skeletal-related events in patients with multiple myeloma.
- A final decision from the European Commission usually takes ~60 days.