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Amgen seeks new denosumab approval


Biotechnology giant Amgen is seeking US approval for the use of its osteoporosis drug denosumab for the reduction of fractures and to prevent bone weakness in patients with advanced cancer.

It is the second application to the US Food and Drug Administration for the experimental medicine. The FDA is due to decide by late July whether to approve denosumab as a treatment for postmenopausal osteoporosis.

Amgen submitted a Biologics License Application to the FDA based on data from three late stage clinical trials comparing denosumab to Novartis AG’s Zometa.

The company’s research chief Roger Perlmutter said. said: “Denosumab demonstrated consistently similar or greater efficacy in clinical trials when compared to zolendronic acid, offering the potential to improve on the current standard of care.

“One potential advantage of denosumab is that dose adjustments resulting from declining renal function are not necessary.”

Amgen said it also plans to submit marketing applications in the European Union, Switzerland, Canada, Australia, and Japan.

The drug, which would be sold under the proposed brand name Prolia, is widely considered to be Amgen’s most important future growth driver, and an additional cancer approval would significantly boost sales.

Mr Perlmutter said: “We believe that denosumab will offer substantial benefit to cancer patients suffering from bone metastases.”

Bone metastases, or the spread of tumours to the skeleton, often see the growing cancer cells weaken and destroy the bone around the tumour, producing serious clinical consequences such as fractures, spinal cord compression, or the need to receive radiation or surgery to bone.

Copyright Press Association 2010

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