Amgen has announced more promising data on its investigational compound denosumab which shows that the monoclonal antibody can prevent osteoporosis in men being treated with prostate cancer drugs which cause bone loss.

The firm said that the three-year study of more than 1,400 men with non-metastatic prostate cancer undergoing androgen deprivation therapy demonstrated that denosumab produced greater increases in bone mineral density at the lumbar spine and non-vertebral sites compared to placebo. Also those receiving denosumab experienced less than half the incidence of new vertebral fractures than those on placebo, Amgen said.

Roger Perlmutter, executive vice president of R&D at Amgen, said that the study “demonstrated once again that denosumab increases BMD consistently at all sites measured”. He added that “we are also excited by the reduction in vertebral fractures, which permits the conclusion that the increased BMD seen in patients receiving denosumab is associated with improved bone strength".

Amgen added that the results are consistent with findings from studies of the drug in women with breast cancer receiving aromatase inhibitor therapy, and in postmenopausal women with low bone mass.

No approval for Nplate – yet
Meantime, Amgen says that a press statement concerning US approval of Nplate (romiplostim) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenic purpura was released by accident by Business Wire. Nplate, is still under regulatory review at the US Food and Drug Administration, and an agency panel recommended approval of the treatment under a restricted distribution programme in March.

The FDA is expected to act on Nplate by July 23.