Testing It Up

A new drug from Amgen received a partial endorsement from a federal advisory committee for the FDA despite product safety concerns. denosumbah, a drug designed to treat post menopausal women with osteoporosis, went before the committee  in the hope of receiving full approval but found itself challenged.

While the committee voted unanimously for the drug’s approval, it also voted 12 to 3 that it should not be approved to treat women with moderately low bone growth and voted against 3 out of four possible uses for use in remedying weakened bones in patients with prostate and breast cancer developed from treatment. The board referred to their concern that the drug had caused a slight increase in certain cancers and infections during clinical trials. As a result the committee felt that it would be best to reserve denosumbah for treatment of high risk cases.

The FDA will decide by October 19^th wether to approve the drug or not. Denosumbah is given in a shot once every 6 months and doesn’t have some the problems that products like Boniva have such as tolerance limits. Denosumbah is a monoclonal antibody which blocks RANK ligand, which encourages the formation and activity of cells that destroy bone.

Tags: bone density, bone drug, bone weakness, drugs, osteoporosis in women, treatment, women

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