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Denosumab hit by FDA safety fears


Safety fears over Amgen’s osteoporosis drug denosumab has prompted the US Food and Drug Administration (FDA) to ban its use as a preventative treatment.

Despite the setback, analysts still expect it to achieve blockbuster sales of between $1 billion and $2 billion.

The FDA said that while the drug helps prevent bone fractures in women with postmenopausal osteoporosis, it should only be used by those who face the greatest risk.

While the FDA agrees that the drug clearly works, it is concerned about evidence of increased rates of skin infections and cancerous tumours seen in company trials.

Amgen is also seeking approval for the drug’s use in patients being treated for breast and prostate cancer. It is considered critical to the company’s future growth, as FDA-imposed safety restrictions have also hit sales of its top-selling anaemia drugs.

Denosumab is a genetically-engineered version of a protein that helps block a biological process that breaks down bone cells.

Copyright Press Association 2009


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