A US drug advisory panel today denied by a 12-1 vote permission for Amgen Inc. (NASDAQ: AMGN) to market its Xgeva prostate cancer as a treatment for slowing the spread of tumors to bones in patients with advanced cases of prostate cancer. The FDA is expected to issue a final ruling on the drug in April.
If Amgen fails to gain approval for the drug, the company could lose about $1 billion in revenue in 2015, when the drug is forecast to generate $3-$4 billion in revenue for the company. Xgeva was approved in 2010 as a treatment to prevent bone pain and fractures caused by bone metastases and is also used to treat osteoporosis in menopausal women.
Amgen’s shares are down about -1.33% at $68.25 in a 52-week range of $47.66-$70.00.
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