FDA advisory committee splits on approval of denosumab


The FDA’s advisory panel has apparently recommended approval of denosumab, but only for some of the indications that were being  requested by the manufacturer. If approved, denosumab will have the trade name Prolia®.

Based on the results of today’s advisory board meeting it appears as though the product will be approved for treating the following groups of patients:

  • Postmenopausal women with osteoporosis with a history of fracture or who are at high risk for fracture
  • “Certain” prostate cancer patients (who presumably are those at risk of bone loss and fractures because they are receiving hormone therapy for progressive and/or metastatic disease)

However, the panel did not recommend approval of the drug for other groups of patients, including:

  • Women with low bone mineral densitywho might benefit from prevention of osteoporosis
  • Women at risk for bone loss associated with treatment of breast cancer with aromatase inhibitors (a type of hormone therapy)

It is clear that there were some differences of opinion between FDA reviewers and the manufacturer over the possibility of serious side effects associated with use of denosumab, most particularly a slight risk for infections and for suppression of the immune system.

For additional information, please see a more detailed report on CNNMoney.com.

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