FDA panel backs Amgen's denosumab, limits use

An FDA expert panel has voted unanimously to back Amgen's closely-watched biologic denosumab for the treatment of osteoporosis in postmenopausal women. However, the panel also supported limiting the use of denosumab to women with a history of fractures or a high risk of fractures, a move likely to slice into the blockbuster drug's market potential.

The experts voted 12-3 that the drug should not be used to prevent the condition in women with low bone mineral density, saying that the risks outweigh potential benefits. And the panel called on the agency to create a rigorous safety review program to gather data on the effects of long-term use. While extensive trial data has demonstrated denosumab's ability to build bone mineral density and prevent fractures, the therapy works by inhibiting a protein that also plays a key role in the immune system. The panel wants long-term data collected to determine just how much d-mab raises the risk of infection and some cancers. Until that data is in hand, the experts said that women should try other drugs first.

Denosumab is the first drug in its class and will now go on to compete against therapies such as Boniva, Fosamax, and Reclast. Amgen has yet to say how much it intends to sell the drug for, but analysts expect it won't be cheap. The drug is injected twice a year, which researchers say should help patients stay compliant with treatment regimens.

- check out Amgen's release [1]
- read the report [2] from the Wall Street Journal

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Amgen makes its case today for denosumab [3]
Denosumab's safety profile a hot topic for panel review [4]
Amgen's denosumab prevents fractures in big cancer study [5]
Amgen shares leap on late-stage denosumab data [6]