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FDA to consider application for denosumab

The US FDA is to consider an application for approval of Amgen's denosumab, the first in a new class of osteoporosis drugs

An advisory committee of the US Food and Drug Adminstration (FDA) are to consider an application for approval of the drug denosumab (Prolia), the first in a new class of osteoporosis drugs.

As well as treating osteoporosis in women, if approved, denosumab would be the first drug specifically for the treatment of osteoporosis in men with prostate cancer. According to the International Osteoporosis Foundation, statistics for the US show that about a third of the two million men with prostate cancer have their risk of osteoporosis sharply increased when they undergo hormone-deprivation therapy to prevent further tumours.

Produced by Amgen, denosumab is a biological agent rather than chemically derived and is likely to be the highest-priced osteoporosis drug in a crowded marketplace. The bisphosphonate drug, Fosamax (produced by Merck), is one of the market leaders for treating osteoporosis in postmenopausal women.

On July 29, Merck issued a statement as a result of bisphosphonates being linked to some cases of jaw necrosis associated with delayed healing and infection often following tooth extraction. Merck said that rare reports consistent with osteonecrosis of the jaw (ONJ) had been received but that many of these reports lacked sufficient clinical details to make definitive assessments and/or are confounded particularly since a generally accepted definition of ONJ in the general population is unknown.

In July 2005, new labelling was issued for Fosamax which included bisphosphonate class labelling for ONJ, at the request of the FDA (with information on ONJ provided in the "adverse reactions" section).

12th August 2009

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