Amgen Inc. said it has sought U.S. regulatory approval of denosumab, a highly anticipated bone loss drug the company hopes will replace its damaged anemia franchise as a sales accelerator for the company.
Thousand Oaks-based Amgen said it filed late Friday a request with the U.S. Food and Drug Administration for approval to market denosumab as a treatment to prevent and treat osteoporosis in postmenopausal women and for patients undergoing breast or prostate cancer treatment.
Noting the potential market and promising clinical trials involving more than 11,000 patients, analysts believe the drug may be Amgen's next billion-dollar blockbuster. Amgen shares, which were hard hit last year due to safety concerns over its Aranesp and Epogen anemia drugs, have been on an upswing this year in part due to denosumab.
If approved, the drug would compete with several other drugs in an osteoporosis drug market that nearly hit $9 billion last year. Amgen said it plans to file similar requests soon with regulators in the European Union, Switzerland, Canada and Australia.
Amgen also is studying the drug as a potential cancer treatment, and said it plans to release study data for that use next year.
Amgen shares were up 62 cents, or 1 percent, to $58.44 in morning trading on the New York Stock Exchange despite an overall market downturn.
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