August 14, 2009
Partial approval for Amgen bone drug
Amgen's bone drug, denosumab, has been partially endorsed by an advisory committee to the U.S. Food and Drug Administration, officials said.
In a unanimous vote Thursday, the committee said denosumab should be approved to treat post menopausal women with osteoporosis, The New York Times reported Friday.
However, the committee voted 12 to 3 against denosumab being used to prevent osteoporosis in women with moderately low bone density, and it opposed three of four possible uses for prostate and breast cancer patients whose therapy can weaken bones.
The committee said it was concerned about a slight increase in some infections and cancers in patients receiving denosumab when compared with those taking placebos in clinical trials.
The FDA tentatively is to decide in October whether to approve the drug, which would be marketed under the name Prolia.
In clinical trials involving 8,000 women, 2.3 percent of those taking denosumab had a vertebral fracture over three years, compared with 7.2 percent of women taking placebos.