THOUSAND OAKS, Calif., May 20, 2011 /PRNewswire/ — Amgen
(Nasdaq:
AMGN) today announced that the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMA) has
recommended a positive opinion for the marketing authorization of
XGEVA™ (denosumab) 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 (EU) 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.
Bone metastases, the spread of cancer to the bones, are a common
and serious concern for patients with advanced cancer and present a
burden to the healthcare system. Weakened bones due to metastases
can lead to fractures and compression of the spinal cord and
necessitate procedures like major surgery and radiation,
collectively called skeletal-related events (SREs). The primary
goal of treatment for bone metastases is to prevent the occurrence
of these debilitating and costly SREs.
“A diagnosis of skeletal-related events associated with bone
metastases is devastating for patients living with cancer, and our
goal is to prevent the occurrence of these debilitating bone
complications, which can disrupt a patient’s life and cause
disability, pain, and hospitalization,” said Willard Dere, M.D.,
senior vice president and international chief medical officer,
Amgen. “XGEVA provides patients with superior efficacy over Zometa
in preventing skeletal-related events in patients with solid tumors
and prolong
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