Amgen files for crucial denosumab approval

Amgen filed for marketing approval of its lead experimental drug on Friday. The biotech giant is looking for agency approval to market denosumab to treat and prevent postmenopausal osteoporosis in women, and bone loss in patients undergoing hormone therapy to treat either prostate or breast cancer. And analysts are paying close attention to the approval process. Amgen is relying on denosumab [1] to supply the company with blockbuster revenues, crucial income as its anemia franchise loses steam.

Amgen went to the FDA armed with a mountain of data. Denosumab has been tested in six late-stage trials involving 11,000 patients. And Amgen has been clear that it intends to line up a marketing partner for the drug. Some analysts tell Dow Jones that Amgen may get a partner better able to market to primary care doctors.

Denosumab is injected twice yearly with no restrictions while the oral drugs available now are administered under tight guidelines. 

- here's Amgen's release [2]
- check out the Dow Jones report [3]

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Amgen shares surge on positive D-mab data [5]
Wall Street swoons over Amgen's D-mab future [6]