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Amgen's denosumab succeeds in key osteoporosis trial
Wednesday 30 July 2008
Tom Moberly - Reporter
Amgen's novel drug denosumab prevents fractures, as well as increasing bone mineral density, in postmenopausal women with osteoporosis, top-line results from a 7,800-patient pivotal Phase III study suggest.
The results of the FREEDOM study mean that Amgen now has all the data necessary for a filing for one of its key pipeline hopes. The company said that it would now make commercial decisions on whether the compound would be filed as a single product for osteoporosis and chemotherapy-induced bone loss or separately for the two indications.
Whereas previous studies of denosumab have examined the surrogate endpoint of bone mineral density (BMD), the FREEDOM study examined as its primary endpoint denosumab's effect on the important clinical outcome of the incidence of new fractures...
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