Amgen Inc. moved to a key stage for its potential blockbuster drug denosumab on Monday when the Food and Drug Administration announced that a panel would review the drug, which is an experimental treatment for osteoporosis, in August.
The FDA said it would ask an advisory panel of outside medical experts to assess the safety and effectiveness of denosumab at a meeting scheduled for Aug. 13. The FDA is not required to follow the panel's advice, though it usually does. The agency is scheduled to make a decision by October.
Amgen, the Thousand Oaks biotech, wants to market denosumab as a treatment for postmenopausal osteoporosis and for the prevention of bone loss in patients being treated for prostate cancer or breast cancer. Applications also are being reviewed by regulators in the European Union and Canada. The drug's proposed trade name is Prolia, the agency said in its announcement.
If approved, denosumab would be a key growth driver for Amgen, since sales of its anemia drugs Aranesp and Epogen have continued to decline due to safety concerns and stricter warnings over the past few years. Analysts forecast denosumab could eventually generate well over $1 billion in annual sales.
Amgen shares were down $1.04, or 2 percent, to $51.30 in morning trading Monday.
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