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FDA committee meeting on Amgen's investigational denosumab to focus on risks, benefits
Wednesday, August 12 2009 | Comments
What's This?
The risks of Amgen Inc.'s investigational monoclonal antibody denosumab--especially when used as a preventative treatment for bone loss--must be weighed against its benefits, according to a Food and Drug Administration briefing document released ahead of an advisory committee meeting.The Division of Reproductive and Urological Products is scheduled meet Thursday to discuss denosumab, which has a proposed brand name of Prolia and four proposed indications: treatment of postmenopausal osteoporosis, prevention of postmenopausal osteoporosis, treatment and prevention of bone loss associated with hormone ablation therapy for breast cancer and treatment and prevention of bone loss associated with hormone ablation therapy for prostate cancer.
The briefing document noted that treatment of postmenopausal osteoporosis would be the biologic's primary indication. The document also noted that the primary safety issues seen during clinical trials of the treatment were serious infection, new malignancies, potential for tumor progression, suppression of bone remodeling and dermatologic adverse events.
"Of particular concern, in light of these safety issues, is whether the risk/benefit balance for the osteoporosis prevention indication, both for patients with and without cancer, supports approval," the FDA said.
The agency noted that, if the drug is approved, it is seeking advice from the committee on whether a risk evaluation and mitigation strategy would be needed.
BMO Markets analyst Jason Zhang was not surprised by the safety issues and said the panel will likely vote for approval of denosumab, Reuters reported. The news service added that Zhang expects the drug to have $2.4 billion in annual sales by 2012.
If approved, denosumab would be the first biologic for the prevention and treatment of postmenopausal osteoporosis and the first product for the treatment and prevention of bone loss associated with hormone ablation therapy in breast and prostate cancer.
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